AlinIQ 03R89-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380740189914), received between Jul 16, 2021 and Aug 27, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Computer Software Problem

  The customer observed mismatched results and COMMUNICATION TIMED OUT errors on the AlinIQ AMS.The customer stated SID (b)(6) (35-year-old female) results (2.55/Reactive) were mismatched with SID (b)(6) (42-year-old female) for HAVAb Ig results (0.26/Nonreactive). The customer stated results were NOT reported outside of the lab and were processed on the Alinity i processing Modules.After AMS LOS driver was upgraded from v4.4.0.0 to v4.4.4.0, no further issues were observed. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484394 ↗
• MalfunctionOct 7, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS ASSIGNED A RESULT GENERATED FROM THE ALINITY TO AN INCORRECT PATIENT SAMPLE (40 YEAR OLD FEMALE, (B)(6). A URINE SAMPLE HAD A DRUG SCREEN AND CREATININE TESTS ORDERED ON IT. IN THE ALINIQ AMS A COCAINE RESULT OF <0.19 WAS SHOWING FOR THE SAMPLE. HOWEVER, THE COCAINE REAGENT WASN¿T LOADED ON THE INSTRUMENT. UPON REVIEW, THE INSTRUMENT RAN A LACTATE TEST ON AN UNREQUESTED URINE SAMPLE, AND THE RESULT WAS ERRONEOUSLY LINKED TO THE COCAINE TEST ON THE ALINIQ AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23233070 ↗
• MalfunctionJun 17, 2024Computer Software Problem; Computer Software Problem

  INCORRECT RESULTS WERE GENERATED AFTER A RULE WAS IMPLEMENTED IN ALINIQ AMS. THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT THE CURRENT ALINIQ AMS RULE ONLY PERFORMS A CONVERSION ON NUMERICAL RESULTS, SO IT DOESN¿T WORK ON < 25 RESULTS FOR ALPHA-1-ANTI-TRYPSIN RESULTS. THE CUSTOMER REQUESTED A NEW RULE SO THAT INSTEAD OF LOW THE RESULT OF <25 WOULD BE NUMERICAL / QUANTITATIVE. THE CUSTOMER CONTACTED ABBOTT FOR A NEWLY REQUESTED RULE. THE NEW RULE WAS ACTIVATED AND TESTING OF THE NEW RULE WAS PLANNED. IN THE PROCESS TO HAVE THE NEW RULE TESTED, TWO SAMPLES GENERATED INCORRECT RESULTS. SAMPLE ID (B)(6) AMS REPORTED ALPHA 1 ANTITRYPSIN RESULT WAS < 0.25, REAL VALUE WAS 1.22. SAMPLE ID (B)(6) AMS REPORTED ALPHA 1 ANTITRYPSIN RESULT WAS < 0.25, REAL VALUE WAS 1.61. UPON REVIEW, THE RESULTS WENT THROUGH EXISTING RULES IN ALINIQ AMS IN ADDITION TO THIS NEW RULE THAT WAS ACTIVATED, WHICH LED TO THE INCORRECT RESULT OUTCOME. ALINIQ AMS SENT THE INCORRECT RESULTS TO THE LIS, HOWEVER THE CUSTOMER CORRECTED THE RESULTS IN LIS BEFORE OFFICIAL REPORTS WERE GIVEN TO PATIENT. THE ALINIQ AMS RULES HAVE BEEN MODIFIED, TESTED, AND EVERYTHING IS NOW WORKING OK. THE CUSTOMER REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553744 ↗
• MalfunctionOct 26, 2023Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER OBSERVED INCORRECT ASSAY RESULTS ON AMS ANIQ SOFTWARE WHICH CONNECTED TO ARCHITECT C16000 PROCESSING MODULE. THE ABBOTT FIELD SERVICE ENGINEER (FSE) PERFORMED TRACK UPGRADE. THE ARCHITECT C16000 PROCESSING MODULE CONNECTED DIRECTLY TO AMS SOFTWARE DURING TRACK UPGRADE. THE FSE PERFORMED THE ASSAY MAPPING ON AMS SOFTWARE DUE TO TRACK UPGRADE. THE FSE INCORRECTLY MAPPED THE ASSAY IRON INSTEAD OF THE ASSAY FERRITIN. THE PHYSICIAN FOUND OUT WHEN RECEIVED THE RESULTS FOR IRON INSTEAD OF THE FERRITIN. THE FERRITIN RESULTS DELAYED DUE TO INCORRECT MAPPING ISSUE ON AMS SOFTWARE BY THE ABBOTT FSE. THE IRON RESULTS REPORTED OUT OF THE LABORATORY INSTEAD OF FERRITIN. THE FSE CONFIGURATED CORRECT ASSAY IN AMS SOFTWARE WHICH RESOLVED THE ISSUE. NO DISCREPANT PATIENT RESULTS PROVIDED BY THE CUSTOMER. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013184 ↗
• MalfunctionOct 12, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE ALINIQ AMS SOFTWARE VERSION 2.12 CONFIGURATION FOR PROGESTERONE RESULTS WAS INCORRECT. THE CUSTOMER FURTHER REPORTED THAT THERE WAS A RULE THAT ALL RESULTS GENERATED WITH A GREATER THAN SIGN (>) OR A LESS THAN SIGN (<) SHOULD BE HELD BY AMS HOWEVER THIS WAS CHANGED AND PROGESTERONE RESULTS >127.2 ARE BEING AUTOMATICALLY RELEASED TO THE LIS (LABORATORY INFORMATION SYSTEM), CAUSING INCORRECT RESULTS TO BE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THIS OCCURRED WITH 4 SAMPLES AND PROVIDED THE FOLLOWING DATA: CUSTOMER PROGESTERONE REFERENCE RANGE: ¿ FOLLICULAR PHASE: < 0.95 NMOL/L. ¿ LUTEAL PHASE: 3.8 - 51 NMOL/L. ¿ POST-MENOPAUSAL: < 0.63 NMOL/L. ¿ 1ST TRIMESTER: 8.9 - 468 NMOL/L. ¿ 2ND TRIMESTER: 72 - 303 NMOL/L. ¿ 3RD TRIMESTER: 89 - 771 NMOL/L. ON (B)(6) 2023 SAMPLE 1 RESULT WAS > 1270 NMOL/L, AMENDED TO 156.4 NMOL/L. ON (B)(6) 2023 SAMPLE 2 RESULT WAS > 0.0 NMOL/L, AMENDED TO 266.8 NMOL/L. ON (B)(6) 2023 SAMPLE 3 RESULT WAS > 0.0 NMOL/L, AMENDED TO 241.7 NMOL/L. ON (B)(6) 2023 SAMPLE 4 RESULT WAS > 0.0 NMOL/L, AMENDED TO 134.8 NMOL/L. IT HAS BEEN REPORTED THAT ALINIQ AMS RULES HAVE BEEN UPDATED FOR THE CUSTOMER. THERE WAS NO REPORTED IMPACT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926647 ↗
• MalfunctionAug 16, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT A RULE ON THE ALINIQ AMS SOFTWARE VERSION 2.10 WAS WORKING PREVIOUSLY AND IS NOW NOT ENABLING HIL (HEMOLYSIS, ICTERUS, LIPEMIA) RULES FOR AN ALINITY C PROCESSING MODULE (SN: (B)(6) ) AND THE CUSTOMER PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6): DUE TO THE HIGH LEVEL OF H, THE RULE SHOULD HAVE REMOVED THE POT AND AST RESULTS, HOWEVER THE RESULTS WERE ABLE TO BE REPORTED OUT OF THE LABORATORY. THE CUSTOMER ALSO REPORTED A TOTAL THERE WAS 14 GROSSLY HEMOLYZED SAMPLES OVER A 12 HR PERIOD. ALL THE AFFECTED PATIENT SAMPLES HAD TO BE RERAN AND, IN SOME CASES, REPEAT SAMPLES SENT TO THE LAB. UPON REVIEW, IT WAS DETERMINED THE INSTRUMENT MODULE WAS NOT CONFIGURED CORRECTLY AND WAS NOT CONVERTED TO A USER-FRIENDLY NAME AND WAS MISSING FROM THE FAMILY RULE, AND THE MODULE WAS ADDED TO THE RULE. THERE HAS BEEN NO KNOWN FURTHER REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561567 ↗
• MalfunctionMay 11, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THE ALINIQ AMS BASE SOFTWARE VERSION 2.12 HAD DEMOGRAPHIC DATA NOT MATCHING BETWEEN THE LIFECARE NOW LIS AND AMS. THERE WAS NO IMPACT AS CUSTOMER REPROCESSED PATIENT WITH A NEW SID NUMBER. THE FOLLOWING DATA WAS PROVIDED: IN LIS LIFECARE NOW: LID NO: (B)(4); PATIENT NO: (B)(6) ; CUSTOMER: (B)(6) ; IN AMS: ID NUMBER (B)(4); PERSONAL ID: (B)(6) CUSTOMER: (B)(6) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914304 ↗
• MalfunctionApr 20, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED AMS ALINIQ SOFTWARE DID NOT HOLD THE 0.90 S/CO SYPHILIS RESULT TILL ALINITY S PROCESSING MODULE PERFORMED DUPLICATE REPEAT RUN FOR GRAYZONE RANGE. THE CUSTOMER HAS GRAYZONE RANGE SETUP 0.90 TO 1.00 S/CO IN ALINITY S PROCESSING MODULE. THOSE GRAYZONE RESULTS NEED TO BE REPEATED IN DUPLICATE ON ALINITY S PROCESSING MODULE BEFORE REPORTED TO LIS. THE AMS HAS CONFIGURED RANGE > 0.90 S/CO FOR SYPHILIS. THE AMS SOFTWARE DID NOT HOLD RESULTS IF EXACT RESULTS 0.90 S/CO. THERE WAS RANGE SETTING DISCREPANCY BETWEEN ALINITY S PROCESSING MODULE AND AMS SOFTWARE. THE ABBOTT FSR CONFIGURED THE RANGE IN AMS SOFTWARE =0.90 S/CO TO 1.00 S/CO FOR HOLD ALL THOSE SCREEN ASSAY HIV, HCV, SYPHILIS AND HBV TILL DUPLICATE RUNS PERFORMED. THERE WAS NO INFORMATION PROVIDED BY THE CUSTOMER FOR DISCREPANT RESULTS REPORTED TO PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778058 ↗
• MalfunctionApr 17, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT DURING ALINIQ AMS CONFIGURATION BY ABBOTT, 379 IRON AND HDL RESULTS WERE RELEASED INCORRECTLY BEFORE VERIFICATION AND LIMS BUILD WAS COMPLETED. ALL THE ASSAYS WERE DISABLED IN THE AMS AUTOMATION AS REQUIRED TO PREVENT RESULTS FROM BEING GENERATED IN A LIVE STATE. HOWEVER, AN AMS SPECIALIST ENABLED THE ASSAYS ON (B)(6) 2023, AND THE CUSTOMER FOUND THE RESULTS WERE THEN BEING RELEASED TO PATIENT CHARTS AND RE-DISENABLED THEM ON (B)(6) 2023. THE PATIENT RESULTS THAT WERE RELEASED DID NOT HAVE REFERENCE RANGES APPLIED TO THEM AND 79 OF THE RESULTS WERE NOT FLAGGED FOR LOW IRON. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750961 ↗
• MalfunctionMar 17, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER OBSERVED THE INCORRECT SAMPLE ID NUMBER PROVIDED BY THE ALINIQ AMS BASE SOFTWARE FOR A PATIENT SAMPLE. SAMPLE (B)(6) DID NOT PROVIDE THE EXPECTED ALIQUOT SAMPLE. THEY RECEIVED AN ALIQUOT WITH SAMPLE NUMBER (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566670 ↗
• MalfunctionFeb 2, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED A PATIENT PROCESSED ON (B)(6) 2023 WITH SID(B)(6) HAD DETAILS FROM A DIFFERENT PATIENT IN THE AMS. THE CORRECT PATIENT DETAILS WERE IN THE LIS THAT MATCHED THE SID THEREFORE THE RESULTS WERE REPORTED CORRECTLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285085 ↗
• MalfunctionFeb 1, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE ALINIQ AMS BASE SOFTWARE VERSION 2.12 DID NOT TRIGGER A RERUN FOR SOME SAMPLES. THE CUSTOMER REPORTED THE PATIENT¿S NAME ON THE ALINIQ AMS WAS DIFFERENT FROM WHAT WAS DISPLAYED ON THE SYSMEX XN1500 ANALYZER AND THEREFORE UNABLE TO TRIGGER A RERUN. WHEN REVIEWING THE AMS LOGS, IT SHOWS THE AMS SENT THE WRONG PATIENT¿S NAME TO THE ANALYZER. THE RESULTS WERE NOT TAGGED TO THE WRONG SID NOR WERE THE RESULTS AFFECTED; ONLY THE PATIENT¿S NAME WAS DISPLAYED WRONG ON THE ANALYZER WHEN RECEIVED FROM THE ALINIQ AMS SOFTWARE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281486 ↗
• MalfunctionJan 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT CSF GLUCOSE RESULTS GENERATED FROM ALINITY C PROCESSING MODULE ON ALINIQ AMS SOFTWARE FOR SEVERAL PATIENTS. DURING THE URINE GLUCOSE VALIDATION, THE CUSTOMER CHANGED UNIT OF MEASURE TO G/L FROM MG/DL. THE CUSTOMER OBSERVED DISCREPANT CSF GLUCOSE RESULTS GENERATED AFTER THE UNIT OF MEASURE CHANGED. THE CUSTOMER OBSERVED 96 DISCREPANT RESULTS FOR CSF GLUCOSE THOSE ARE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE ANY DISCREPANT PATIENT RESULTS. THE CUSTOMER AGREES THAT ISSUE AFTER UNIT OF MEASURE CHANGED DURING VALIDATION BY THE CUSTOMER. THE CUSTOMER CHANGED BACK TO CORRECT UNIT OF MEASURE TO MG/DL PER ALINITY C GLUCOSE PACKAGE INSERT. OBTAINED CORRECT INFORMATION ON 17MAR2023: THE CUSTOMER OBSERVED DISCREPANT CAVITY FLUID GLUCOSE RESULTS NOT CSF GLUCOSE RESULTS GENERATED FROM ALINITY C PROCESSING MODULE ON ALINIQ AMS SOFTWARE FOR SEVERAL PATIENTS. THE CUSTOMER OBSERVED 96 DISCREPANT RESULTS FOR CAVITY FLUID GLUCOSE THOSE ARE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243636 ↗
• MalfunctionDec 5, 2022Computer Software Problem; Computer Software Problem

  THE CUSTOMER OBSERVED MIXED RESULTS BETWEEN TWO ALINIQ AMS TEST CODES. THE ISSUE OCCURRED WHILE THE CUSTOMER WAS IMPLEMENTING AND TESTING A NEW RULE FOR INTERPRETING RESULTS. THE RULE WAS INTENDED FOR ASSAYS THAT REQUIRE RETESTS IN WHICH THE FINAL INTERPRETATION IS ONLY SENT AFTER THE INITIAL AND TWO ADDITIONAL RETESTS WERE COMPLETED. WHILE TESTING OF THE RULE PATIENT TUBES WERE PLACED ON THE TRACK, MEASURED AND THE RESULTS WERE REPORTED. IT WAS SUBSEQUENTLY DISCOVERED THAT THE RESULTS WERE MIXED UP BETWEEN TWO AMS TEST CODES. A LOOK BACK WAS COMPLETED AND SAMPLE ID (B)(6) ANTI-HBC RESULTS WERE IMPACTED BY THE ERROR. THE INTERPRETATION (POS/NEG) WAS CORRECT HOWEVER FOR EACH SAMPLE ONE OF THE VALUES WAS HAVAB IGG. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914430 ↗
• MalfunctionOct 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED FALSELY DECREASED RESULTS FROM ANIQ AMS SOFTWARE FOR SEVERAL NEWBORN PATIENTS. THE AMS SOFTWARE HAS WRONG UNIT OF MEASURE 2500 GRAM ENTERED FOR APR TESTING BY THE ABBOTT FIELD REPRESENTATIVE (FSR). THE APR UNIT SUPPOSED TO BE IN 2.5 KILOGRAM. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) ENTERED WRONG UNIT OF MEASURE FOR APR TESTING. THE APR CALCULATION OUT OF THOSE TESTING C-REACTIVE PROTEIN (CRP), 1-ACID GLYCOPROTEIN, HAPTOGLOBIN. THE APR CALCULATION IS FORMULA DERIVED FROM C-REACTIVE PROTEIN (CRP), 1-ACID GLYCOPROTEIN, HAPTOGLOBIN. THE APR CALCULATION USED FOR NEWBORN INFECTION OR SEPSIS. THE INCORRECT APR RESULTS REPORTED OUT OF THE LABORATORY, HOWEVER THAT FORMULA CHANGED IN SOFTWARE BY THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WITH CORRECT THE UNIT OF MEASURE AS 2.5 KILOGRAM. THERE WERE NO ACTUAL RESULTS PROVIDED FOR CRP, 1-ACID GLYCOPROTEIN, HAPTOGLOBIN. NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581110 ↗
• MalfunctionApr 25, 2022No Device Output; No Device Output

  ABBOTT HAS BEEN NOTIFIED OF A PATIENT DEATH ON (B)(6) 2022. THE CUSTOMER REPORTED TREATMENT WAS NOT PROVIDED TO A PATIENT AS A RESULT OF A DELAY IN GENERATING ALINITY I CORTISOL RESULTS WHILE USING THE ALINITY I PROCESSING MODULE. REVIEW OF THE EVENT IDENTIFIED THAT THERE WAS AN APPROXIMATELY 30-HOUR TIMEFRAME BETWEEN WHEN THE SAMPLE WAS INTRODUCED TO THE TRACK SYSTEM AND THE ANALYZER PROVIDING RESULTS TO THE CUSTOMER [REQUEST RECEIVED (B)(6) 2021 AT 08:58. CORTISOL RESULT RETURNED ON (B)(6) 2021 AT 14:25 (30 HOURS 27 MINUTES)]. THE CUSTOMER STATED THE CLINICAL TEAM DID NOT TREAT THE PATIENT WITH HYDROCORTISONE MEDICATION IN A TIMELY MANNER AS THEY WERE NOT AWARE OF THE LOW CORTISOL STATUS. THE SAMPLE RETURNED A CORTISOL RESULT OF <27.6 [LINEAR RANGE OF THE ASSAY IS 27.6 TO 1649.9 NMOL/L]. THE PATIENT WAS TESTED FOR CORTISOL ON THE DAY PRIOR ((B)(6)2021 09:30 AM) WITH RESULT 132. THE CUSTOMER DOES NOT QUESTION THE CORTISOL RESULTS GENERATED. THE PATIENT WAS A 78-YEAR-OLD MALE WHO REPORTED HEADACHE AND VOMITING. THE (B)(6) WAS PROVIDED. THE FOLLOWING RESULTS WERE GENERATED: SODIUM 144, POTASSIUM 3.4 LOW, UREA 7.8, CREATININE 142 HIGH, CRP 55 HIGH, CORTISOL <28 LOW, PROLACTIN 102, TE

  Patient problems: Insufficient Information

  MAUDE report 14192526 ↗
• MalfunctionApr 1, 2022Computer Software Problem; Installation-Related Problem; Computer Software Problem; Installation-Related Problem

  THE CUSTOMER OBSERVED A SOFTWARE ISSUE WITH THE ALINIQ AMS 2.12. THE CUSTOMER REPORTED THAT HDL TEST ORDERS SENT BY THE LIS WERE MISMATCHED ON THE AMS WITH THE LDH TEST. THE AMS WAS CONFIGURED FOR THE HDL ASSAY ON (B)(6) 2022. THE AMS AND ALINITY ANALYZER WERE CONNECTED TO THE LIS ON (B)(6) 2022 AND ONLY THE HDL ORDERS WERE AFFECTED FROM (B)(6). THE AMS CONFIGURATION WAS MODIFIED ON (B)(6) AND THE 241 SAMPLES WITH HDL ORDERS WERE RERUN TO CORRECT THE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978855 ↗
• MalfunctionJul 16, 2021Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT FOR APPROXIMATELY 85 PATIENT SAMPLES MANAGED JOINTLY BY ABBOTT AND ROCHE, WHEN ALL THE SAMPLES HAVE BEEN TESTED BY THE ABBOTT ANALYZER AND PRODUCED RESULTS, THE AMS ADDED A NEW RULE TO SET THE DEFAULT VALUE OF 1 FOR THE ROCHE CLASSIFIED ASSAYS (S_ROCHE). THIS DEFAULT IS NOT SHIELDED AND WILL ALSO BE TRANSMITTED TO THE LIS, MEANING ALL RESULTS THAT ARE CLASSIFIED S_ROCHE WILL BE SENT TO THE LIS AS 1. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180358 ↗