Biotestcell® Pool 816065100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969952670), received between Apr 28, 2017 and Jun 26, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WITH BIOTESTCELL POOL (REF #816065100, LOT #8015011-00) ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT WAS TESTED AT ANOTHER FACILITY AND THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-K (KEL1). THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL POOL (REF 816065100, LOT 8015011-00) WITH SERACLONE ANTI-K IN THE TUBE TEST WITH AN INCUBATION FOR 5 MINUTES AT ROOM TEMPERATURE AND WITH A POLYCLONAL ANTI-K IN THE INDIRECT ANTIGLOBULIN TEST (IAT). THE POOLED CELL (DONOR (B)(6), K+K+) YIELDED A CORRECT POSITIVE RESULT IN BOTH TESTS. THE CUSTOMER DID NOT PROVIDE RESULT IMAGES OR THE LOG FILES FOR ANALYSIS OF THE TANGO INFINITY'S FUNCTION. LAST PREVENTIVE MAINTENANCE WAS IN JANUARY 2020. WITHOUT LOG FILES AN ANALYSIS OF THE INSTRUMENT'S FUNCTION IS NOT POSSIBLE. ACCORDING TO THE FIELD SERVICE ENGINEER THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATION. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE RETENTION SAMPLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199007 ↗
• MalfunctionJan 6, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL POOL ON TANGO OPTIMO. THE PATIENT HAD A KNOWN ANTI-K. THE CUSTOMER STATED THAT THE ANTIBODY WAS DETECTED IN THE TUBE AND THE GEL METHOD. THE REACTION STRENGTH WAS 1 TO 2+ POSITIVE. IN OUR INITIAL REPORT, THE DATE OF EVENT WAS ERRONEOUSLY STATED AS (B)(6) 2019 WHEN IT SHOULD HAVE BEEN (B)(6) 2019. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL POOL. AT THE TIME WE RECEIVED THE SUPPOSEDLY DEFECTIVE PRODUCT IT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE CURRENT LOT OF BIOTESTCELL POOL ON TANGO OPTIMO. THE PATIENT SAMPLE YIELDED A WEAK POSITIVE REACTION. WITHIN ITS SHELF LIFE, OUR QC LAB TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE BIOTESTCELL POOL LOT WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO OPTIMO, E.G. AN ANTI-K. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED IN THE GEL TECHNIQUE AND YIELDED A WEAK POSITIVE R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9552690 ↗
• MalfunctionApr 28, 2017False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL POOL ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS AN ANTI-K. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE WHICH HAD CAUSED A FALSE NEGATIVE TEST RESULT. BECAUSE ONLY A VERY SMALL QUANTITY OF THE COMPLAINT SAMPLE WAS PROVIDED BY THE CUSTOMER IT WAS NOT POSSIBLE TO TEST THIS SAMPLE ON TANGO INFINITY. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THEIR RETAINED SAMPLE OF BIOTESTCELL POOL ON TANGO INFINITY AND YIELDED A CORRECT POSITIVE RESULT. THE RETAINED SAMPLE WAS ALSO TESTED WITH DIFFERENT SAMPLES AND CONTROLS, INCLUDING ANTI-K ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL POOL FUNCTIONS CORRECTLY. 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 INFINITY WAS CHECKED BY A FIELD S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529087 ↗