ABBOTT PRISM 6E66-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740062965), received between May 10, 2017 and Jul 6, 2022 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, 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 ↗
• 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 ↗
• MalfunctionAug 28, 2018False Negative Result; False Negative Result

  DURING A CLINICAL EVALUATION STUDY USING PRISM HBCORE 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 HBCORE ASSAY FOR SAMPLE W14091712311000 WAS IDENTIFIED DURING THE COURSE OF THE STUDY. THE SAMPLE TESTED POSITIVE ON ARCHITECT CORE-M. 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 7824140 ↗
• MalfunctionMay 10, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A DONOR UNIT THAT WAS COLLECTED ON (B)(6) 2016 GENERATED A (B)(6) ABBOTT PRISM HBCORE RESULT. THE CUSTOMER INDICATED THE DONOR UNIT GENERATED ULTRIO NAT (B)(6). WHEN SEPARATED OUT FOR INDIVIDUAL TESTING, (B)(6). THE CUSTOMER FURTHER INDICATED THE (B)(6) RESULTS WERE CONSIDERED TO BE FROM THE WINDOW PHASE OF DETECTION BY PRISM AND THE BLOOD UNIT WAS FROZEN FOR POTENTIAL COMMERCIAL RESALE. THE DONOR UNIT WAS NOT TRANSFUSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559252 ↗