ABBOTT PRISM 6D18-68Recalls & reported problems
Abbott Laboratories · ABBOTT PRISM HCV Assay Kit
Quick summary
This Abbott PRISM HCV assay kit is a laboratory test used to screen donated blood for hepatitis C. The 31 reports mostly describe results that came back reactive or positive even though confirmatory testing showed the samples were negative, along with a smaller number of missed or unusually high results. No deaths or injuries were reported, and none of the reports describe impact on patient care. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380740062996), received between Nov 21, 2016 and Nov 1, 2021 — classified as 31 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (20 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
Device problems
- False Positive Result20
- False Negative Result5
- High Test Results5
- Incorrect Or Inadequate Test Results1
Patient problems
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2021False Negative Result; False Negative Result
THE CUSTOMER OBSERVED (B)(6) ABBOTT PRISM ANTI- HCV ASSAY ON ONE DONOR SPECIMENS WHEN COMPARING TO ALINITY S PROCESSING MODULE. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) =(B)(6) / REPEATED ON ALINITY S=(B)(6) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12729274 ↗MalfunctionOct 27, 2021False Negative Result; False Negative Result
THE CUSTOMER OBSERVED A (B)(6) ABBOTT PRISM HCV RESULT FOR A DONOR SPECIMEN WHEN COMPARING TO THE ALINITY S ANALYZER. THE FOLLOWING RESULTS PROVIDED: ON (B)(6) 2021 SAMPLE ID (B)(6): PRISM (01293) HCV RESULT = (B)(6), NAT = (B)(6), ALINITY S ANTI - HCV RESULTS = (B)(6) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12707937 ↗MalfunctionApr 13, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED (B)(6) PRISM CHAGAS, PRISM (B)(6), AND PRISM HTLV RESULTS WERE GENERATED. THE CUSTOMER STATED THAT THE SAMPLES WERE ARCHIVED THEN RUN ON THE ALINITY S FOR VALIDATION TESTING AS ¿KNOWN¿ (B)(6) BUT THEY GENERATED (B)(6) RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6)- (B)(6) 2021 PRISM CHAGAS REPEAT PRISM CHAGAS REPEAT REACTIVE (1.40, 1.47, 1.39 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.14 S/CO); ESA INDETERMINATE SID (B)(6)- (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.78, 2.61, 2.55 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.02 S/CO); ESA NEGATIVE SID (B)(6) - (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.94, 1.88, 1.76 S/CO);(B)(6) 2021- ALINITY S NON-REACTIVE (0.14 S/CO); MP HTLV BLOT NEGATIVE SID (B)(6)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.93, 2.01, AND 1.99 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.13 S/CO); MP HTLV BLOT INDETERMINATE SID (B)(6)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.25, 1.47, 1.39 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.16 S/CO); MP HTLV BLOT INVALID SID (B)(6)- (B)(6) 2021 PRISM (B)(6) REPEAT (B)(6); (B)(6) 2021- ALINITY S (B)(6); ORTHO (B)(6), ROCHE NAT (B)(6) THERE WAS NO R
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656353 ↗MalfunctionJan 8, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. TWENTY-SEVEN (27) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9563956 ↗MalfunctionJan 8, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. TWENTY-SEVEN (27) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9563939 ↗MalfunctionJan 7, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE POSITIVE (B)(6) RESULTS ON THE PRISM ANALYZER. TWENTY-SEVEN (27) RESULTS WERE REPEAT REACTIVE AND CONFIRMED NEGATIVE ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9560085 ↗MalfunctionDec 26, 2019High Test Results; High Test Results
THE CUSTOMER OBSERVED FALSE POSITIVE ANTI-HCV RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 1.47, REPEAT 1.27, 1.25 S/CO, SID (B)(6) INITIAL 1.28, REPEAT 1.41, 1.42 S/CO, SID (B)(6) INITIAL 1.74, REPEAT 1.45, 1.57 S/CO. THE SAMPLES WERE NAT NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9521760 ↗MalfunctionDec 16, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS FOR TWO DONOR SAMPLES. THE CUSTOMER INDICATED THE DONORS' PREVIOUS AND SUBSEQUENT DONATION WERE NON-REACTIVE. DONOR 1: (B)(6) 2019 ID (B)(6) NON-REACTIVE, (B)(6) 2019 ID (B)(6) REPEAT REACTIVE, (B)(6) 2019 ID (B)(6) NON-REACTIVE. DONOR 2: (B)(6) 2019 ID (B)(6)NON-REACTIVE, (B)(6) 2019 ID (B)(6) REPEAT REACTIVE, (B)(6) 2019 ID (B)(6) NON-REACTIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9475721 ↗MalfunctionSep 24, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE PRISM ANTI-HCV RESULTS ON 8 DONOR SAMPLES THAT ARE NAT AND CONFIRMATORY NEGATIVE. THE SIDS PROVIDED WERE RUN BETWEEN (B)(6) 2019 THRU (B)(6) 2019:SID (B)(6). THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9110016 ↗MalfunctionSep 24, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED (B)(6) PRISM ANTI-HCV RESULTS ON 8 DONOR SAMPLES THAT ARE NAT AND CONFIRMATORY (B)(6). THE SIDS PROVIDED WERE RUN BETWEEN (B)(6) 2019 THRU (B)(6) 2019: SID (B)(6). THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9109984 ↗MalfunctionSep 24, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REPEAT (B)(6) PRISM ANTI-HCV RESULTS ON 8 DONOR SAMPLES THAT ARE NAT AND CONFIRMATORY (B)(6). THE SIDS PROVIDED WERE RUN BETWEEN 08JUL2019 THRU 08AUG2019: (B)(6). THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9109962 ↗MalfunctionJul 8, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS ON ELEVEN SAMPLES THAT WERE NEGATIVE BY NAT TESTING ON COBAS. NO SPECIFIC DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8769188 ↗MalfunctionJul 8, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS ON ELEVEN SAMPLES THAT WERE NEGATIVE BY NAT TESTING ON COBAS. NO SPECIFIC DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8769168 ↗MalfunctionJul 8, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS ON ELEVEN SAMPLES THAT WERE NEGATIVE BY NAT TESTING ON COBAS. NO SPECIFIC DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8769106 ↗MalfunctionFeb 15, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS. SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM HCV REPEAT REACTIVE AND NEGATIVE ON NAT CONFIRMATORY ASSAY. SAMPLE ID (B)(6): (B)(6) YEAR OLD FEMALE, PRISM HCV REPEAT REACTIVE AND NEGATIVE ON NAT CONFIRMATORY ASSAY. SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM HCV REPEAT REACTIVE AND NEGATIVE FOR HCV NAT CONFIRMATORY ASSAY. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8344019 ↗MalfunctionNov 16, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED MULTIPLE FALSE REACTIVE RESULTS WHILE USING PRISM ANTI-HCV REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (USING LOT 87016M500) INITIAL 1.21 S/CO (REACTIVE), REPEAT 1.02, 1.08 S/CO (REACTIVE). SID (B)(6) INITIAL (USING LOT 87016M500) 1.01 S/CO (REACTIVE), REPEAT (USING LOT 88041M500) 0.68 S/CO (NONREACTIVE), 1.05 S/CO (REACTIVE). SID (B)(6) (USING LOT 88041M500) INITIAL 1.28 S/CO (REACTIVE), REPEAT 1.18, 1.09 S/CO (REACTIVE) THE SPECIMENS WERE NONREACTIVE USING HCV NAT. NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8081933 ↗MalfunctionNov 16, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED MULTIPLE FALSE REACTIVE RESULTS WHILE USING PRISM ANTI-HCV REAGENTS. THE FOLLOWING DATA WAS PROVIDED. (B)(6). THE SPECIMENS WERE (B)(6) USING HCV NAT. NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8081926 ↗MalfunctionAug 28, 2018False Negative Result; False Negative Result
DURING A CLINICAL EVALUATION STUDY USING PRISM HCV AS THE PREDICATE PRODUCT, A DONOR SPECIMEN TESTED ON PRISM WAS FOUND TO BE DISCORDANT RELATIVE TO ANOTHER SUPPLEMENTAL METHOD BEING USED FOR FINAL RESULT INTERPRETATION. A (B)(6) SAMPLE ON THE PRISM HCV ASSAY FOR SAMPLE (B)(6) WAS IDENTIFIED DURING THE COURSE OF THE STUDY. WHILE THE SAMPLE WAS ALSO (B)(6), A (B)(6) RESULT WAS OBTAINED WITH A SUPPLEMENTAL TEST. THE DONOR WAS DEFERRED AND THE BLOOD PRODUCT WAS DESTROYED; THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824302 ↗MalfunctionAug 28, 2018False Negative Result; False Negative Result
DURING A CLINICAL EVALUATION STUDY USING PRISM HCV AS THE PREDICATE PRODUCT, A DONOR SPECIMEN TESTED ON PRISM WAS FOUND TO BE DISCORDANT RELATIVE TO ANOTHER SUPPLEMENTAL METHOD BEING USED FOR FINAL RESULT INTERPRETATION. A FALSE NON-REACTIVE SAMPLE ON THE PRISM HCV ASSAY FOR SAMPLE W14161747858200 WAS IDENTIFIED DURING THE COURSE OF THE STUDY. WHILE THE SAMPLE WAS ALSO NAT NEGATIVE, A POSITIVE RESULT WAS OBTAINED WITH A SUPPLEMENTAL TEST. THE DONOR WAS DEFERRED AND THE BLOOD PRODUCT WAS DESTROYED; THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824277 ↗MalfunctionAug 28, 2018False Negative Result; False Negative Result
DURING A CLINICAL EVALUATION STUDY USING PRISM HCV AS THE PREDICATE PRODUCT, A DONOR SPECIMEN TESTED ON PRISM WAS FOUND TO BE DISCORDANT RELATIVE TO ANOTHER SUPPLEMENTAL METHOD BEING USED FOR FINAL RESULT INTERPRETATION. A FALSE NON-REACTIVE SAMPLE ON THE PRISM HCV ASSAY FOR SAMPLE W14091710591400 WAS IDENTIFIED DURING THE COURSE OF THE STUDY. WHILE THE SAMPLE WAS ALSO NAT NEGATIVE, A POSITIVE RESULT WAS OBTAINED WITH A SUPPLEMENTAL TEST. THE DONOR WAS DEFERRED AND THE BLOOD PRODUCT WAS DESTROYED; THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824183 ↗MalfunctionMar 7, 2018High Test Results; High Test Results
THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE PRISM HCV ASSAY ON THE PRISM 6 CHANNEL ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR A MALE PEDIATRIC PATIENT: SID: (B)(6), (B)(6) 2018: PRISM RESULTS: INITIAL RESULT: (B)(6), RETEST RESULTS (AFTER CENTRIFUGATION): (B)(6). THE SPECIMEN WAS ALSO (B)(6) WHEN TESTED USING THE ORTHO HCV ELISA METHOD (S/CO): (B)(6), RETEST RESULTS: (B)(6). (B)(6) TESTING WERE EACH (B)(6). THERE HAS BEEN NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7321522 ↗MalfunctionAug 4, 2017False Positive Result; False Positive Result
THE CUSTOMER OBSERVED AN INCREASE IN REPEAT (B)(6) RESULTS AFTER SWITCHING TO PRISM (B)(6) REAGENT LOT 74080M500 IN (B)(6) 2017. THE REPEAT (B)(6) SAMPLES WERE SENT OUT FOR CONFIRMATORY TESTING AND MOST OF THE RESULTS CAME BACK (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6767657 ↗MalfunctionAug 3, 2017False Positive Result; False Positive Result
THE CUSTOMER OBSERVED AN INCREASE IN REPEAT REACTIVE RESULTS AFTER SWITCHING TO PRISM HCV REAGENT LOT 74080M500. THE REPEAT REACTIVE SAMPLES WERE SENT OUT FOR CONFIRMATORY TESTING AND MOST OF THE RESULTS CAME BACK NONREACTIVE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6764713 ↗MalfunctionMay 24, 2017High Test Results; High Test Results
THE CUSTOMER REPORTED INCREASE IN REPEAT (B)(6) PRISM (B)(6) AND PRISM (B)(6) RESULTS IN (B)(6) 2017. OF 14 (B)(6) SAMPLES 7 WERE (B)(6) WITH (B)(6). SUPPLEMENTAL/CONFIRMATORY TESTING WAS PERFORMED WITH ORTHO (B)(6) (2 (B)(6), 5 NOT TESTED); ORTHO (B)(6) ALL 7 (B)(6); ABBOTT (B)(6) ESA (6 (B)(6), ONE NOT TESTED). THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587629 ↗MalfunctionMay 24, 2017High Test Results; High Test Results
THE CUSTOMER REPORTED INCREASE IN REPEAT (B)(6) PRISM CHAGAS AND PRISM HCV RESULTS IN (B)(6) 2017. OF 14 (B)(6) CHAGAS SAMPLES 7 WERE (B)(6) WITH HCV. SUPPLEMENTAL/CONFIRMATORY TESTING WAS PERFORMED WITH ORTHO CHAGAS (2 NEGATIVE, 5 NOT TESTED); ORTHO HCV ALL 7 (B)(6); ABBOTT CHAGAS ESA (6 (B)(6), ONE NOT TESTED). THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587627 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.