Biotestcell® 3 816085100Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07611969952687), received between Oct 11, 2016 and Oct 1, 2024 — classified as 44 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (36 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS DURING ANTIBODY SCREEN TESTING ON A RHOGAM PATIENT USING BIOTESTCELL 3 ON TANGO INFINITY. AN INITIALLY WEAK POSITIVE RESULT WAS NEGATIVE WHEN RETESTED. THE CUSTOMER ANNOUNCED TO PROVIDE THE ORIGINAL SAMPLES FOR INVESTIGATIONAL TESTING BUT SO FAR, WE HAVE NOT RECEIVED THEM. THE INFORMATION, WHICH LOT OF BIOTESTCELL 3 WAS USED FOR TESTING, WAS ONLY PROVIDED ON SEPTEMBER 27, 2024. AT THAT IME THE PRODUCT HAD ALREADY EXPIRED (SEPTEMBER 23, 2024). THEREFORE, IT WAS NOT POSSIBLE TO TEST THE RETENTION SAMPLE OF THE AFFECTED LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION 0F THE AFFECTED TANGO INFINITY INSTRUMENT IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342482 ↗
• MalfunctionOct 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS DURING ANTIBODY SCREEN TESTING ON A RHOGAM PATIENT USING BIOTESTCELL 3 ON TANGO INFINITY. AN INITIALLY WEAK POSITIVE RESULT WAS NEGATIVE WHEN RETESTED. THE CUSTOMER ANNOUNCED TO PROVIDE THE ORIGINAL SAMPLES FOR INVESTIGATIONAL TESTING BUT SO FAR, WE HAVE NOT RECEIVED THEM. THE INFORMATION, WHICH LOT OF BIOTESTCELL 3 WAS USED FOR TESTING, WAS ONLY PROVIDED ON SEPTEMBER 27, 2024. AT THAT IME THE PRODUCT HAD ALREADY EXPIRED (SEPTEMBER 23, 2024). THEREFORE, IT WAS NOT POSSIBLE TO TEST THE RETENTION SAMPLE OF THE AFFECTED LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION 0F THE AFFECTED TANGO INFINITY INSTRUMENT IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342381 ↗
• MalfunctionJul 23, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A PATIENT SAMPLE THAT HAD A POSITIVE ANTIBODY SCREEN ON TANGO INFINITY WHEN USING BIOTESTCELL 3. THE SCREENING WAS REPEATED AND YIELDED A NEGATIVE.RESULT. TESTING WAS REPEATED THE NEXT DAY USING THE SAME TANGO INFINITY AND THE SAME BIOTESTCELL 3 VIAL. ALL CELLS WERE NEGATIVE. FURTHERMORE ALL PANEL CELLS USING BIOTESTCELL I-11 PLUS (PLEASE ALSO SEE RELATED REPORT 9610824-2024-00030) WERE NEGATIVE. A CONSULTED REFERENCE LABORATORY IDENTIFIED A WARM AUTO ANTIBODY. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFTECTED LOT OF BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL DEPARTMENT TESTED TWO KNOWN ANTIBODIES (ANTI-K, ANTI-C), A POSITIVE CONTROL (SOLIDSCREEN II CONTROL) AND A NEGATIVE CONTROL (SOLIDSCREEN II NEGATIVE CONTROL) WITH BIOTESTCELL 3, LOT 9426011-00 (CURRENT LOT) AND WITH THE COMPLAINED REAGENT BIOTESTCELL I-11 PLUS, LOT 9422011-00 (SEE ALSO 9610824-2024- 00030). ALL REACTIONS OF THE REAGENT RED BLOOD CELLS WERE CLEARLY POSITIVE WITH THE CORRESPONDING ANTIBODY. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS.A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803857 ↗
• MalfunctionJul 23, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A PATIENT SAMPLE THAT HAD A POSITIVE ANTIBODY SCREEN ON TANGO INFINITY WHEN USING BIOTESTCELL 3. THE SCREENING WAS REPEATED AND YIELDED A NEGATIVE RESULT. TESTING WAS REPEATED THE NEXT DAY USING THE SAME TANGO INFINITY AND THE SAME BIOTESTCELL 3 VIAL. ALL CELLS WERE NEGATIVE. FURTHERMORE ALL PANEL CELLS USING BIOTESTCELL I-11 PLUS (PLEASE ALSO SEE RELATED REPORT 9610824-2024-00030) WERE NEGATIVE. A CONSULTED REFERENCE LABORATORY IDENTIFIED A WARM AUTO ANTIBODY. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED LOT OF BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL DEPARTMENT TESTED TWO KNOWN ANTIBODIES (ANTI-K, ANTI-C), A POSITIVE CONTROL (SOLIDSCREEN II CONTROL) AND A NEGATIVE CONTROL (SOLIDSCREEN II NEGATIVE CONTROL) WITH BIOTESTCELL 3, LOT 9426011-00 (CURRENT LOT) AND WITH THE COMPLAINED REAGENT BIOTESTCELL I-11 PLUS, LOT 9422011-00 (SEE ALSO REPORT 9610824-2024- 00030). ALL REACTIONS OF THE REAGENT RED BLOOD CELLS WERE CLEARLY POSITIVE WITH THE CORRESPONDING ANTIBODY. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS WITH THE ALLEGEDLY DEFECTIVE PRODUCT. A REVIEW OF THE BAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803856 ↗
• MalfunctionJan 26, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF CELL 3 OF BIOTESTCELL 3 WITH ANTI-JKB ALBACLONE IN THE TUBE TEST. FURTHERMORE, THE CUSTOMER STATED THAT HE REPEATED THE TESTING WITH A NEW SET OF BIOTESTCELL 3 (BUT SAME LOT) AND RECEIVED AGAIN A FALSE POSITIVE RESULT. THE CUSTOMER STATED THAT THE REACTION STRENGTH OF THE FALSE POSITIVE REACTION WAS 3+ POSITIVE. ACCORDING TO THE ANTIGEN TABLE CELL NO. 3 OF BIOTESTCELL 3 (DONOR NO. (B)(6)) WAS JKA+B-. THE CUSTOMER ANNOUNCED TO SEND IN A SAMPLE OF THE PRODUCT FOR INVESTIGATION. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL OF CUSTOMER TO ARRIVE, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. BIOTESTCELL 3 WAS TESTED WITH SERACLONE ANTI-JKA AND SERACLONE ANTI-JKB. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND MATCHED THE RESULTS OF THE ANTIGEN TABLE: CELL NO.1 JKA+B+, CELL NO. 2 JKA-B+ AND CELL NO. 3 JKA+B-. ADDITIONALLY, THE RETENTION SAMPLE OF BIOTESTCELL 3 WAS TESTED WITH A POLYCLONAL ANTI-JKB IN THE INDIRECT ANTI-GLOBULIN TEST (IAT, 30 MINUTES INCUBATION AT 37°C) AND THE LISS-IAT (10 MINUTES INCUBATION AT 37°C). AGAIN, ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. AT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585622 ↗
• MalfunctionJul 6, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH BIOTESTCELL 3 ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-FYB. . THE CUSTOMER STATED THAT THE ANTIBODY YIELDED CORRECTLY POSITIVE RESULTS IN THE TUBE TEST WITH THE ENHANCEMENT OF PEG (POLYETHYLENE-GLYCOL), BUT A NEGATIVE RESULT IN THE LISS-IAT (INDIRECT ANTIGLOBULIN TEST WITH A LOW IONIC STRENGTH SOLUTION (LISS). THE ANTIBODY SCREENING TEST ON TANGO INFINITY IS ALSO A LISS-IAT. THE INVESTIGATION OF THE AFFECTED LOT OF BIOTESTCELL 3 IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. REGARDING THE AFFECTED TANGO INFINITY, THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW CLEAR NEGATIVE RESULTS ON P1 AND P2 CELLS. A FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT. HE COLLECTED INFINITY TOOL DATA AND IMAGES OF PATIENT (B)(6). HE VERIFIED THAT THE CAMERA VALUES WERE WITHIN TOLERANCE AND NO ADJUSTMENT WAS NEEDED. HER CHECKED THE INSTRUMENT'S WORKING CONDITION AND FOUND THE SPOLV DELIVERY AND WASHING ACTION ARE WORKING AS INTENDED. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. FROM TODAY'S PERSPECTIVE WE CAN SAY THAT THE INSTRUMENT IS WORKING WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14931524 ↗
• MalfunctionJul 6, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH BIOTESTCELL 3 ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-FYB. . THE CUSTOMER STATED THAT THE ANTIBODY YIELDED CORRECTLY POSITIVE RESULTS IN THE TUBE TEST WITH THE ENHANCEMENT OF PEG (POLYETHYLENE-GLYCOL), BUT A NEGATIVE RESULT IN THE LISS-IAT (INDIRECT ANTIGLOBULIN TEST WITH A LOW IONIC STRENGTH SOLUTION (LISS). THE ANTIBODY SCREENING TEST ON TANGO INFINITY IS ALSO A LISS-IAT. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT ANNOUNCED TO SHIP THE PRODUCT SAMPLE, THE AFFECTED ANTI-HUMAN GLOBULIN AND THE SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THE MATERIAL HAS NOT ARRIVED YET. WHILE WAITING OF THE MATERIAL FROM THE CUSTOMER TO ARRIVE ON OUR PREMISES, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON TANGO INFINITY. THE TESTING WAS PERFORMED AMONG OTHERS WITH TWO DIFFERENT ANTI-FYB. IN BOTH CASES THE FYB POSITIVE REAGENT RED BLOOD CELLS #1 AND #2 OF BIOTESTCELL 3 SHOWED CORRECTLY POSITIVE RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14928375 ↗
• MalfunctionJan 28, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE ANTIBODY SCREEN FOR ANTI-C WITH BIOTESTCELL 3 (P2 AND P3 NEGATIVE) AND WITH BIOTESTCELL I11 WHEN TESTED ON TANGO INFINITY. IN GEL SCREEN AND PANEL THE ANTI-C WAS DETECTED. THE QC WORKED FOR ALL CELLS THE DAY OF TESTING. THE EXACT DATE OF EVENT IS NOT KNOWN. THE CUSTOMER DID NOT PROVIDE RESULT IMAGES. WE REQUESTED FURTHER INFORMATION REGARDING THE AFFECTED TANGO INFINIY. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE IN PARALLEL WITH THE CURRENT LOT OF BIOTESTCELL 3 AND DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY, E.G. DIFFERENT ANTI-C ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT, THE ROOT CAUSE ANALYSIS IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242913 ↗
• MalfunctionMay 5, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH BIOTESTCELL 3 ON THE TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-C. THE ANTI-C WAS DETECTED AND IDENTIFIED IN THE MANUAL GEL METHOD. THE CUSTOMER SENT A TANGO INFINITY IMAGE WHICH SHOWED THE NEGATIVE RESULT WITH THE C POSITIVE CELL #1 OF BIOTESTCELL 3. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 FOR INVESTIGATIONAL TESTING, THE AFFECTED ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II AND TWO PATIENT SAMPLES (LABELED AS (B)(6)). ACCORDING TO THE DOCUMENTATION PROVIDED BY THE CUSTOMER ONLY SAMPLE (B)(6) WAS PROCESSED ON TANGO INFINITY. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE (B)(6) WITH THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLE OF BIOTESTCELL 3 ON THE TANGO INFINITY AND COULD CONFIRM THE CUSTOMER¿S FINDING. THE PATIENT SAMPLE YIELDED A NEGATIVE RESULT. ADDITIONALLY THE COMPLAINT SAMPLE AS WELL AS THE RETENTION SAMPLE WERE TESTED WITH DIFFERENT CONTROLS AND SAMPLES, E.G. ANTI-C, ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. DUE TO THE LOW AMOUNT OF PATIENT SAMPLE (B)(

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10023826 ↗
• MalfunctionApr 21, 2020False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF BIOTESTCELL 3 WITH THE CONTROL REAGENT OF A COMPETITOR. THE CUSTOMER STATED THAT THEY SEE FALSE NEGATIVE REACTIONS WITH CELL 3 OF BIOTESTCELL 3 IN THE MANUAL TUBE TEST. THE CUSTOMER COULD NOT PROVIDE THE SPECIFICITY OF THE CONTROL REAGENT, BUT ONLY THE INFORMATION THAT IT IS SUPPOSED TO REACT POSITIVELY WITH CELL 3 OF BIOTESTCELL 3. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE BIOTESTCELL 3 FOR INVESTIGATIONAL TESTING AND ALSO THE AFFECTED ANTI-HUMAN GLOBULIN, BUT NOT THE CONTROL REAGENT OF THE COMPETITOR. AT THE TIME WE RECEIVED THE CUSTOMER'S MATERIAL THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 WAS ALREADY EXPIRED. BUT WITHIN ITS SHELF LIFE OUR QUALITY CONTROL LABORATORY HAD MANUALLY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE BIOTESTCELL 3 LOT WITH DIFFERENT CONTROLS AND SAMPLES, E.G. ANTI-C, ANTI-FY(A) AND ANTI-FY(B). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY THE RH PHENOTYPE AND THE K (KEL1), S (MNS3) AND S (MNS4) ANTIGENS OF CELL #3 WERE CONFIRMED. OUR QUALITY CONTROL LABORATORY ALSO TESTED THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG PROVIDED BY TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9980795 ↗
• MalfunctionJan 7, 2020False Negative Result

  THE CUSTOMER REPORTED A SUPPOSEDLY FALSE (B)(6) REACTION WHEN USING BIOTESTCELL 3 ON TANGO INFINITY. INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. AN INTERNAL QUALITY NOTIFICATION FOR EXCEEDING THE REPORTING DEADLINE TO FDA HAS BEEN RAISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9556624 ↗
• MalfunctionNov 27, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF ONE SPECIMEN WHEN TESTED WITH BIOTESTCELL 3 ON THE TANGO INFINITY DURING INSTRUMENT VALIDATION. THE CUSTOMER STATED THAT THE SPECIMEN CONTAINED AN ANTI-C WHICH REACTED POSITIVE IN THE GEL METHOD. THE CUSTOMER ALSO REPORTED THAT CELL #1 WHICH IS SUPPOSED TO BE C POSITIVE LOOKED FUNKY AND THEREFORE SHE EDITED THE RESULT TO POSITIVE. THE CUSTOMER REPEATED THE TEST TWO DAYS LATER AND YIELDED A 1+ POSITIVE RESULT WITH CELL #1. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SPECIMEN THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER AS WELL AS THEIR RETENTION SAMPLE WITH THE SPECIMEN ON TANGO INFINITY AND YIELDED A WEAK POSITIVE REACTION WITH CELL #1 OF BIOTESTCELL 3. BASED ON THE CORRECT POSITIVE RESULT WITH BIOTESTCELL 3 ON TANGO INFINITY OUR QUALITY CONTROL LABORATORY DID NOT PERFORM FURTHER INVESTIGATION OF THE SPECIMEN. THE RETURNED PRODUCT SAMPLE AS WELL AS THE RETENTION SAMPLE OF BIOTESTCELL 3 WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9382752 ↗
• MalfunctionOct 2, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING TESTS OF TWO PATIENT SAMPLES WITH BIOTESTCELL 3 ON TANGO INFINITY. BOTH PATIENTS HAD RECEIVED ANTEPARTUM ANTI-D PROPHYLAXIS. THE TESTS WERE DONE ON SEPTEMBER 04 (PATIENT 1) AND SEPTEMBER 05 (PATIENT 2), 2019. THE INSTRUMENT CALLED BOTH ANTIBODY SCREENING TESTS NEGATIVE. THE CUSTOMER STATED THAT ENLARGED IMAGES OF CELL #1 AND #2 FOR BOTH PATIENTS SHOWED WEAK POSITIVE REACTIONS, WITH CELL #1BEING WEAKER THAN CELL #2. THE TEST ON SEPTEMBER 04, 2019 WAS REPORTED AS NEGATIVE. THE TEST ON SEPTEMBER 05, 2019 WAS CAUGHT AND EDITED TO POSITIVE BEFORE REPORTING. THE CUSTOMER PROVIDED THE ALLEGEDLY DEFECTIVE SAMPLE OF BIOTESTCELL 3, THE AFFECTED REAGENTS ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II AND SOLIDSCREEN AS WELL AS BOTH PATIENT SAMPLES (LABELED AS BB192450025 AND BB192460108) WHICH CAUSED FALSE NEGATIVE REACTIONS. AT THE TIME WE RECEIVED THE MATERIAL FROM THE CUSTOMER THE SUPPOSEDLY DEFECTIVE LOT BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THE CURRENT LOT OF BIOTESTCELL 3 (LOT # 8939011-00) WITH THE SOLIDSCREEN PLATE AND THE AHG RETURNED BY THE CUSTOMER ON TAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9144300 ↗
• MalfunctionOct 2, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING TESTS OF TWO PATIENT SAMPLES WITH BIOTESTCELL 3 ON TANGO INFINITY. BOTH PATIENTS HAD RECEIVED ANTEPARTUM ANTI-D PROPHYLAXIS. THE TESTS WERE DONE ON (B)(6) (PATIENT 1) AND (B)(6) (PATIENT 2), 2019. THE INSTRUMENT CALLED BOTH ANTIBODY SCREENING TESTS NEGATIVE. THE CUSTOMER STATED THAT ENLARGED IMAGES OF CELL #1 AND #2 FOR BOTH PATIENTS SHOWED WEAK POSITIVE REACTIONS, WITH CELL #1BEING WEAKER THAN CELL #2. THE TEST ON (B)(6) 2019 WAS REPORTED AS NEGATIVE. THE TEST ON (B)(6) 2019 WAS CAUGHT AND EDITED TO POSITIVE BEFORE REPORTING. THE CUSTOMER PROVIDED THE ALLEGEDLY DEFECTIVE SAMPLE OF BIOTESTCELL 3, THE AFFECTED REAGENTS ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II AND SOLIDSCREEN AS WELL AS BOTH PATIENT SAMPLES (LABELED AS (B)(6) AND BB192460108) WHICH CAUSED FALSE NEGATIVE REACTIONS. AT THE TIME WE RECEIVED THE MATERIAL FROM THE CUSTOMER THE SUPPOSEDLY DEFECTIVE LOT BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THE CURRENT LOT OF BIOTESTCELL 3 (LOT # 8939011-00) WITH THE SOLIDSCREEN PLATE AND THE AHG RETURNED BY THE CUSTOMER ON TANGO INFINITY. BOTH PATIENT SAMPL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9144299 ↗
• MalfunctionApr 10, 2019False Negative Result; Defective Device

  THE CUSTOMER REPORTED THAT THEY WERE USING BIOTESTCELL 3 WITH ORTHO GEL CARDS AND THEY WERE WORRIED THAT THEY WOULD NOT PICK UP WEAK ANTIBODIES ON HETEROZYGOUS CELLS. THE CUSTOMER STATED THAT A PATIENT SAMPLE YIELDED A 1+ POSITIVE REACTION WITH CELL #1 OF BIOTESTCELL 3. THE ANTIBODY SEEMED TO BE A WEAK REACTING ANTI-JK(A) AND DUE TO THE SPECIFICITY THE PATIENT SAMPLE WAS SUPPOSED TO REACT POSITIVE ALSO WITH CELL #3. THE CUSTOMER ALSO TESTED THE PATIENT SAMPLE WITH BIOTESTCELL 3 IN THE TUBE METHOD AND RECEIVED A NEGATIVE REACTION. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH BIOTESTCELL 3 IN THE IH-GELCARD AND COULD CONFIRM THE CUSTOMER´S FINDING: THE JKA HOMOZYGOUS (JKA+B-) CELL #1 REACTED POSITIVE WHILE THE JKA HETEROZYGOUS CELL (JKA+B+) CELL #3 SHOWED A NEGATIVE RESULT. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED IN THE TUBE TECHNIQUE AND YIELDED COMPLETELY NEGATIVE RESULTS. FURTHERMORE THE RETENTION SAMPLE OF BIOTESTCELL 3 WAS TESTED WITH AN ANTI-JKA. BOTH, CELL #1 AND #3 SHOWED CORRECTLY POSITIVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8499473 ↗
• MalfunctionSep 19, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESPECTIVELY DISCREPANT ANTIBODY SCREEN RESULTS FOR ANTI-C WHEN TESTING WITH BIOTESTCELL 3 ON TANGO OPTIMO. THE REACTION IN ONE OF THE CELLS APPEARED VISUALLY POSITIVE (1+) BUT TANGO OPTIMO GAVE A NEGATIVE REACTION. THE SAMPLE WAS RE-TESTED IN THE TUBE TEST AND YIELDED A POSITIVE SCREEN AND IT WAS IDENTIFIED AS AN ANTI-C. THE CUSTOMER RETURNED THE PATIENT SAMPLES THAT HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND FOUND TO BE WORKING WITHIN SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888757 ↗
• MalfunctionAug 23, 2018False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL 3 ON TANGO INFINITY. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE KNOWN ANTIBODY IS AN ACQUIRED ANTI-D DUE TO THE RH(D) PROPHYLAXIS. HE ALSO STATED THAT THE REACTION WITH CELL #1 OF BIOTESTCELL 3 WAS VISUALLY POSITIVE, BUT CALLED NEGATIVE BY THE INSTRUMENT. THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING BUT A PATIENT SAMPLE LABELLED AS #0811:BB3. THE PATIENT SAMPLE THE CUSTOMER PROVIDED WAS NOT THE ONE WITH THE MISSED ACQUIRED ANTI-D, BUT A PATIENT SAMPLE WITH AN ANTI-E. THE CUSTOMER STATED THAT THIS PATIENT SAMPLE YIELDED A 1+ POSITIVE REACTION ON ONE TANGO INFINITY AND A NEGATIVE (BUT VISUALLY WEAK POSITIVE) REACTION ON THE OTHER TANGO INFINITY. AT THE TIME WE RECEIVED THE PATIENT SAMPLE THE AFFECTED LOT OF BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE THE PATIENT SAMPLE WAS TESTED WITH THE CURRENT SAMPLE OF BIOTESTCELL #3 (LOT #8831011-00) AND YIELDED A NEGATIVE RESULT. ADDITIONALLY THE SAMPLE WAS TESTED WITH BIOTESTCELL-I11. DUE TO THE LACK OF SAMPLE MATERIAL THE RESULTS OF TANGO INFINITY COULD NOT BE ASSESSED. ADDITIONAL TESTS WERE NOT POSSIBLE, BECAUSE TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808414 ↗
• MalfunctionAug 20, 2018False Negative Result; Defective Component

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL 3 ON TANGO INFINITY. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE KNOWN ANTIBODY IS ANTI-K. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THE CUSTOMER ALSO RETURNED THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II. AT THE TIME WE RECEIVED THE CUSTOMER'S BIOTESTCELL 3 SAMPLE THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THEIR RETENTION SAMPLE OF THE CURRENT LOT OF BIOTESTCELL 3 AND THE AHG ANTI-IGG SOLIDSCREEN II RETURNED BY THE CUSTOMER ON TANGO INFINITY. THE PATIENT SAMPLE YIELDED A CORRECT POSITIVE RESULT WITH THE KELL POSITIVE CELL #2 OF BIOTESTCELL 3. ADDITIONALLY THE CUSTOMER'S AHG ANTI-IGG SOLIDSCREEN II OF CUSTOMER WAS TESTED FOR POTENCY AND SPECIFICITY AND MET ALL ACCEPTANCE CRITERIA. DURING ITS SHELF LIFE THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE BIOTESTCELL 3 LOT WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY, E.G. ANTI-K FROM AN INTERLABORATORY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796962 ↗
• MalfunctionJun 19, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN IMMUCOR ECHO AND TANGO INFINITY. CUSTOMER RAN A PATIENT SAMPLE THAT WAS 4+ POS FOR ANTI-JKA ON TWO DIFFERENT IMMUCOR ANALYZERS AND YIELDED A POSITIVE RESULT. TESTING THE SAME TUBE WAS RUN ON TANGO INFINITY WITH BIOTESTCELL 3, # 8815021-00 AND BIOTESTCELL-11, #8817011-00 AND THE RESULTS WERE NEGATIVE. THE CUSTOMER DID NEITHER PROVIDE THE PATIENT SAMPLES HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING NOR THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL 3 WITH DIFFERENT SAMPLES AND CONTROLS (E.G. : ANTI-D, ANTI-JKA) ON TANGO INFINITY. THE REAGENTS THAT WERE USED FOR TESTING ON CUSTOMERS SITE WERE ALSO USED FOR QC TESTING. ALL TEST RESULTS WERE AS EXPECTED, ALL POSITIVE REACTIONS WERE CLEARLY POSITIVE, NO IRREGULARITIES WERE FOUND. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION OF ALL THREE BATCHES SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOTS. THE INVOLVED TANGO INFINIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7612881 ↗
• MalfunctionJun 19, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN IMMUCOR ECHO AND TANGO INFINITY. CUSTOMER RAN A PATIENT SAMPLE THAT WAS 4+ POS FOR ANTI-JKA ON TWO DIFFERENT IMMUCOR ANALYZERS AND YIELDED A POSITIVE RESULT. TESTING THE SAME TUBE WAS RUN ON TANGO INFINITY WITH BIOTESTCELL 3, # 8815021-00 AND BIOTESTCELL-11, #8817011-00 AND THE RESULTS WERE NEGATIVE. THE SAME SAMPLE WAS RUN ON A SECOND TANGO INFINITY AND THE RESULTS WERE ALSO NEGATIVE. THE CUSTOMER DID NEITHER PROVIDE THE PATIENT SAMPLES HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING NOR THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL 3 WITH DIFFERENT SAMPLES AND CONTROLS (E.G. : ANTI-D, ANTI-JKA) ON TANGO INFINITY. THE REAGENTS THAT WERE USED FOR TESTING ON CUSTOMERS SITE WERE ALSO USED FOR QC TESTING. ALL TEST RESULTS WERE AS EXPECTED, ALL POSITIVE REACTIONS WERE CLEARLY POSITIVE, NO IRREGULARITIES WERE FOUND. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION OF ALL THREE BATCHES SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7612880 ↗
• MalfunctionApr 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Defective Device

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TWO TANGO INFINITY ANALYZERS WITH BIOTEST CELL 3. ON ONE ANALYZER THE RESULT WAS POSITIVE BUT NEGATIVE ON THE OTHER ANALYZER. THE CUSTOMER STATED THAT FOUR SAMPLES OF TWO DIFFERENT PATIENTS WERE AFFECTED. BOTH PATIENTS HAD RECEIVED RH(D) PROPHYLAXIS AND DUE TO THIS SAMPLES WERE SUPPOSED TO YIELD POSITIVE REACTIONS WITH THE RH(D) POSITIVE SCREENING CELLS #1 AND #2 OF BIOTEST CELL-3. THE TWO SAMPLES ON EACH PATIENT WERE PRE- AND POST-DELIVERY. THE CUSTOMER STATED THAT THE POSITIVE REACTIONS WERE +/- RESPECTIVELY 1+ POSITIVE. THE CUSTOMER RETURNED THE FOUR SAMPLES OF THE TWO PATIENTS (EACH PRE- AND POST-DELIVERY) THAT HAD CAUSED FALSE NEGATIVES FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THEIR RETENTION SAMPLE OF BIOTEST CELL 3 ON TANGO INFINITY. ONE PRE-DELIVERY SAMPLE YIELDED A CORRECTLY WEAK POSITIVE RESULT, BUT THE OTHER PRE-DELIVERY SAMPLE AND BOTH POST-DELIVERY SAMPLE YIELDED NEGATIVE RESULTS. THREE OF THE FOUR SAMPLES WERE ADDITIONALLY TESTED IN THE GEL TECHNIQUE WITH ENZYME TREATED REAGENT RED BLOOD CELLS AND YIELDE

  Patient problems: Overdose

  MAUDE report 7435754 ↗
• MalfunctionApr 17, 2018False Positive Result; Defective Component

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TWO TANGO INFINITY ANALYZERS WITH BIOTEST CELL 3. ON ONE ANALYZER THE RESULT WAS POSITIVE BUT NEGATIVE ON THE OTHER ANALYZER. THE CUSTOMER STATED THAT FOUR SAMPLES OF TWO DIFFERENT PATIENTS WERE AFFECTED. BOTH PATIENTS HAD RECEIVED RH(D) PROPHYLAXIS AND DUE TO THIS SAMPLES WERE SUPPOSED TO YIELD POSITIVE REACTIONS WITH THE RH(D) POSITIVE SCREENING CELLS #1 AND #2 OF BIOTEST CELL-3. THE TWO SAMPLES ON EACH PATIENT WERE PRE- AND POST-DELIVERY. THE CUSTOMER STATED THAT THE POSITIVE REACTIONS WERE +/- RESPECTIVELY 1+ POSITIVE. THE CUSTOMER RETURNED THE FOUR SAMPLES OF THE TWO PATIENTS (EACH PRE- AND POST-DELIVERY) THAT HAD CAUSED FALSE NEGATIVES FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THEIR RETENTION SAMPLE OF BIOTEST CELL 3 ON TANGO INFINITY. ONE PRE-DELIVERY SAMPLE YIELDED A CORRECTLY WEAK POSITIVE RESULT, BUT THE OTHER PRE-DELIVERY SAMPLE AND BOTH POST-DELIVERY SAMPLE YIELDED NEGATIVE RESULTS. THREE OF THE FOUR SAMPLES WERE ADDITIONALLY TESTED IN THE GEL TECHNIQUE WITH ENZYME TREATED REAGENT RED BLOOD CELLS AND YIELDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7435750 ↗
• MalfunctionApr 17, 2018Defective Component

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TWO TANGO INFINITY ANALYZERS WITH BIOTESTCELL 3. ON ONE ANALYZER THE RESULT WAS POSITIVE BUT NEGATIVE ON THE OTHER ANALYZER. THE CUSTOMER STATED THAT FOUR SAMPLES OF TWO DIFFERENT PATIENTS WERE AFFECTED. BOTH PATIENTS HAD RECEIVED RH(D) PROPHYLAXIS AND DUE TO THIS SAMPLES WERE SUPPOSED TO YIELD POSITIVE REACTIONS WITH THE RH(D) POSITIVE SCREENING CELLS #1 AND #2 OF BIOTESTCELL-3. THE TWO SAMPLES ON EACH PATIENT WERE PRE- AND POST-DELIVERY. THE CUSTOMER STATED THAT THE POSITIVE REACTIONS WERE +/- RESPECTIVELY 1+ POSITIVE. THE CUSTOMER RETURNED THE FOUR SAMPLES OF THE TWO PATIENTS (EACH PRE- AND POST-DELIVERY) THAT HAD CAUSED FALSE NEGATIVES FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THEIR RETENTION SAMPLE OF BIOTESTCELL 3 ON TANGO INFINITY. ONE PRE-DELIVERY SAMPLE YIELDED A CORRECTLY WEAK POSITIVE RESULT, BUT THE OTHER PRE-DELIVERY SAMPLE AND BOTH POST-DELIVERY SAMPLE YIELDED NEGATIVE RESULTS. THREE OF THE FOUR SAMPLES WERE ADDITIONALLY TESTED IN THE GEL TECHNIQUE WITH ENZYME TREATED REAGENT RED BLOOD CELLS AND YIELDED VE

  Patient problems: Reaction

  MAUDE report 7435749 ↗
• MalfunctionMar 8, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF TWO PATIENT SAMPLES WITH BIOTESTCELL 3 WHEN USED ON TANGO OPTIMO. THE SPECIFICITY OF THE MISSED ANTIBODIES WAS ANTI-E. THE ANTIBODIES WERE DETECTED WITH THE ENHANCEMENT MEDIUM POLYETHYLENE GLYCOL (PEG). THE CUSTOMER SAID TO SEND IN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLES THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY HAS NOT RECEIVED THEM SO FAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322847 ↗
• MalfunctionNov 16, 2017Device Expiration Issue; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH A HISTORY OF AN ANTI-E WHEN TESTED WITH BIOTEST CELL 3 ON TANGO OPTIMO. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT AND THE AFFECTED CELL #2 OF THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL 3. THE CUSTOMER PROVIDED TWO PATIENT SAMPLES LABELLED (B)(6). ACCORDING TO THE CUSTOMER'S DOCUMENTATION THE SAMPLES ARE FROM THE SAME PATIENT BUT WITH DIFFERENT DATES OF WITHDRAWAL. AT THE TIME WE RECEIVED THE PATIENT SAMPLES AND THE COMPLAINT SAMPLE THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS THE PATIENT SAMPLES WERE TESTED WITH THE COMPLAINT SAMPLE OF BIOTEST CELL 3 ON TANGO OPTIMO. WE COULD CONFIRM THE CUSTOMER´S FINDING. THE PATIENT SAMPLES WERE TESTED WITH A CURRENT LOT OF BIOTEST CELL 3 AND YIELDED THE SAME RESULT. ADDITIONALLY THE PATIENT SAMPLES WERE TESTED IN DIFFERENT TUBE METHODS. BOTH PATIENT SAMPLES YIELDED CLEARLY STRONG POSITIVE RESULTS ONLY WHEN USING THE ENZYME METHOD. IN THE INDIRECT ANTI-HUMAN GLOBULIN TEST THE REACTIONS WERE NEGATIVE. THE TANGO OPTIMO ALSO USES THE INDIRECT ANTI-HUMAN GLOBULIN METHOD. AS A SUMMARY OF ALL TEST RESULTS THE AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037072 ↗