ABBOTT PRISMRecalls & reported problems across all models
Abbott Laboratories · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 145
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 9 models of ABBOTT PRISM by Abbott Laboratories in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Jul 6, 2022 — classified as 3 injuries, 142 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported ABBOTT PRISM problems
Device problems
- False Positive Result92
- High Test Results21
- Calibration Error13
- False Negative Result13
- Low Test Results3
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
- Failure to Calibrate1
Patient problems
- No Known Impact Or Consequence To Patient99
- No Consequences Or Impact To Patient19
- No Patient Involvement14
- No Clinical Signs, Symptoms or Conditions10
- Eye Injury1
- Injury1
- Insufficient Information1
- No Code Available1
ABBOTT PRISM models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 47 reports
- 31 reports
- 18 reports
- 17 reports
- 11 reports
- 11 reports
- ABBOTT PRISM 6A36-11TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN4 reports
- 4 reports
- ABBOTT PRISM 6A36-34TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN2 reports
Recent ABBOTT PRISM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2022False Positive Result; False Positive Result
THE CUSTOMER STATED THAT A FALSE REACTIVE PRISM HBCORE RESULT WAS GENERATED. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2022. SAMPLE ID (B)(6). HBCORE RESULTS: REPEAT REACTIVE 0.89, 0.93, AND 0.94 S/CO. THE SAMPLE TESTED NONREACTIVE ON THE ALINITY S PROCESSING MODULE WHICH IS BELIEVED TO BE CORRECT. SUPPLEMENTAL TESTING WAS NONREACTIVE/NEGATIVE FOR HBSAG AND HBV PCR. NO IMPACT TO DONOR OR PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14936088 ↗MalfunctionJul 6, 2022False Positive Result; False Positive Result
THE CUSTOMER STATED THAT A FALSE REACTIVE PRISM CHAGAS RESULT WAS GENERATED. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2022. SAMPLE ID: (B)(4). CHAGAS RESULTS: REPEAT REACTIVE 2.01, 2.01, AND 2.32 S/CO THE SAMPLE TESTED NONREACTIVE ON THE ALINITY S PROCESSING MODULE (0.06 S/CO) WHICH IS BELIEVED TO BE CORRECT. CONFIRMATORY TESTING WAS NEGATIVE. NO IMPACT TO DONOR OR PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14936033 ↗MalfunctionFeb 21, 2022False Positive Result; False Positive Result
ARCHIVED CUSTOMER SAMPLES WERE RETURNED AND EVALUATED IN-HOUSE BY ABBOTT ON ESA CHAGAS. SAMPLES CHAGAS POS 05, CHAGAS POS 08, CHAGAS POS 17, AND CHAGAS POS 18 WERE CONFIRMED TO BE NONREACTIVE. THEREFORE, TEST RESULTS OBTAINED ON PRISM CHAGAS FOR THESE TWO SAMPLES ARE CONSIDERED FALSE REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13567520 ↗MalfunctionJan 6, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED (B)(6) PRISM HTLV-I/HTLV-II RESULTS ON MULTIPLE PATIENTS WHEN PERFORMING A VALIDATION STUDY ON THE ALINITY S ANALYZER. ALL OF THE (B)(6) PRISM SAMPLES TESTED NEGATIVE ON THE ALINITY S. WESTERN BLOT (WB) TESTING WAS (B)(6) FOR ALL BUT ONE SAMPLE, WHICH WAS INDETERMINATE (IND). RESULTS PROVIDED: (B)(6) RESULTS (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177770 ↗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 ↗MalfunctionOct 5, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS FOR ONE DONOR ON (B)(6) 2021. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT ON SN (B)(6) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576751 ↗MalfunctionApr 13, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE PRISM CHAGAS, PRISM HCV, 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¿ POSITIVES BUT THEY GENERATED NON-REACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.40, 1.47, 1.39 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.54 S/CO); ESA INDETERMINATE. SID (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) 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) 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) 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) 2021 PRISM HCV REPEAT REACTIVE (1.26, 1.20, 1.24 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.06 S/CO); ORTHO HCV NONREACTIVE, ROCHE NAT NEGATIVE THER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656377 ↗MalfunctionApr 13, 2021False Positive Result; False Positive Result
THE CUSTOMER REPORTED FALSE REPEAT REACTIVE PRISM CHAGAS, PRISM HCV, 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¿ POSITIVES BUT THEY GENERATED NON-REACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.40, 1.47, 1.39 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.54 S/CO); ESA INDETERMINATE. SID (B)(6) PRISM CHAGAS REPEAT REACTIVE (1.78, 2.61, 2.55 S/CO) (LOT 15094M700); 1(B)(6) 2021- ALINITY S NON-REACTIVE (0.02 S/CO); ESA NEGATIVE. SID (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.94, 1.88, 1.76 S/CO); 19MAR2021- ALINITY S NON-REACTIVE (0.14 S/CO); MP HTLV BLOT NEGATIVE. SID (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) 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) 2021 PRISM HCV REPEAT REACTIVE (1.26, 1.20, 1.24 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.06 S/CO); ORTHO HCV NONREACTIVE, ROCHE NAT NEGATIVE THERE WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656363 ↗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 ↗MalfunctionDec 18, 2020False Negative Result; False Negative Result
THE CUSTOMER GENERATED A FALSE NONREACTIVE ABBOTT PRISM CHAGAS RESULT FOR ONE DONOR. THE CUSTOMER WAS PERFORMING A VALIDATION STUDY BETWEEN ALINITY S CHAGAS AND PRISM CHAGAS ASSAYS. THE CUSTOMER WAS USING THE PRISM ASSAY AS THE TEST OF RECORD. THE FOLLOWING DATA WAS PROVIDED FROM THE SAMPLE THAT WAS COLLECTED ON (B)(6) 2020: SAMPLE ID (B)(6) INITIAL PRISM RESULT, ON (B)(6) 2020, WAS 0.17 S/CO, WHICH IS NONREACTIVE. THE SAMPLE WAS TESTED ON THE ALINITY S, ON (B)(6) 2020, AND THE RESULT WAS 1.42, REPEATS WERE 1.46 AND 1.57 S/CO, WHICH ARE REACTIVE. THE SAMPLE WAS POSITIVE WHEN TESTED WITH THE ABBOTT ESA CHAGAS. THIS IS A REPEAT DONOR WHO HAD A PREVIOUS NONREACTIVE RESULT. THE DONATED UNIT OF BLOOD WAS RECALLED BY THE CUSTOMER, QUARANTINED, AND DISCARDED ON (B)(6) 2020. THERE WAS NO DONOR DEMOGRAPHIC INFORMATION PROVIDED. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11038199 ↗MalfunctionApr 8, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE PRISM (B)(6) CONFIRMATORY RESULTS FOR 1 SAMPLE. THE SAMPLE TESTED NEGATIVE WITH NAT TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2020, SID (B)(6), (B)(6) RESULTS = 6.97, 6.80, 6.91 S/CO (REACTIVE). (B)(6) RESULTS = 0.04, 0.04, 0.04 S/CO (REACTIVE). (B)(6) CONFIRMATORY: CONFIRMED POSITIVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9940709 ↗MalfunctionApr 6, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE ABBOTT PRISM (B)(6) AND ABBOTT PRISM (B)(6) RESULTS FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6): (B)(6) RESULTS = 6.97, 6.80, 6.91 (REACTIVE). (B)(6) CONFIRMATORY RESULTS FROM ANOTHER ANALYZER = POSITIVE. (B)(6) RESULTS = 0.04, 0.04, 0.04 (REACTIVE). THE SAMPLE IS NEGATIVE WITH NAT TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9929839 ↗MalfunctionApr 6, 2020False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE REACTIVE ABBOTT PRISM (B)(6) AND ABBOTT PRISM (B)(6) RESULTS FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6) 2020 SID (B)(6): (B)(6) RESULTS = 6.97, 6.80, 6.91 (REACTIVE), (B)(6) CONFIRMATORY RESULTS FROM ANOTHER ANALYZER = POSITIVE, (B)(6) RESULTS = 0.04, 0.04, 0.04 (REACTIVE) . THE SAMPLE IS NEGATIVE WITH NAT TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9929816 ↗MalfunctionJan 10, 2020False Positive Result; False Positive Result
THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATES FOR (B)(6) RESULTS WHEN PROCESSING ON THE PRISM. SAMPLES WERE RETESTED IN DUPLICATE AND THE RESULTS WERE REACTIVE. THE CUSTOMER STATED CONFIRMATORY TESTING WAS NONREACTIVE. ADDITIONAL TESTING WITH WESTERN BLOT AND (B)(6) EIA WAS ALSO NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9573678 ↗
Other Abbott Laboratories products
All Abbott Laboratories devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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