ABBOTT PRISM 6D19-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380740062989), received between Feb 21, 2017 and Apr 6, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 11, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A (B)(6) PRISM HBSAG RESULT ON ONE DONOR. THE RESULTS PROVIDED WERE: (B)(6). THE SAMPLE HAD NEUTRALIZING CONFIRMATORY TESTING PERFORMED: (B)(6). THE SAMPLES TESTED NEGATIVE FOR NAT AND (B)(6). THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781724 ↗
• MalfunctionSep 24, 2018False Positive Result; False Positive Result

  THE ACCOUNT GENERATED A FALSE REACTIVE, CONFIRMED (B)(6) PRISM HBSAG RESULT ON A PLASMA DONOR WHO TESTED NAT HBV, HIV, HBCORE AND HCV NEGATIVE AND PRISM HBSAG NEGATIVE (SAMPLE DRAW DATES OF (B)(6) 2018 AND (B)(6) 2018). SID (B)(6) (SAMPLE DRAW DATE OF (B)(6) 2018) TESTED PRISM HBSAG INITIAL, REPEAT AND CONFIRMED (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE POSITIVE PLASMA UNIT WAS NOT RELEASED FOR USE. NO SPECIFIC DONOR INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904078 ↗
• MalfunctionAug 21, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DONOR GENERATED FALSE REPEAT REACTIVE, CONFIRMED (B)(6) PRISM (B)(6) RESULTS. (B)(6) WAS PRISM HBSAG REPEAT REACTIVE AND SENT TO A REFERENCE LAB WHICH GENERATED CONFIRMED (B)(6) RESULTS ID (B)(6) (PLASMA BAG ALIQUOT FROM SAME DONOR) WAS PRISM (B)(6) REPEAT REACTIVE AND SENT TO THE REFERENCE LAB GENERATING NONCONFIRMING PRISM (B)(6) RESULTS. ADDITIONAL DONOR TESTING WAS NAT AND ANTI-HBC NEGATIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802509 ↗
• MalfunctionAug 21, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DONOR GENERATED (B)(6) REPEAT (B)(6), CONFIRMED (B)(6) PRISM HBSAG RESULTS. ID (B)(6) WAS PRISM HBSAG REPEAT RB)(6) AND SENT TO A REFERENCE LAB WHICH GENERATED CONFIRMED (B)(6) PRISM HBSAG RESULTS. ID (B)(6) PLASMA BAG ALIQUOT FROM SAME DONOR) WAS PRISM HBSAG REPEAT (B)(6) AND SENT TO THE REFERENCE LAB GENERATING (B)(6) PRISM HBSAG RESULTS. ADDITIONAL DONOR TESTING WAS NAT AND ANTI-HBC (B)(6) . NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802459 ↗
• MalfunctionApr 14, 2018False Negative Result; False Negative Result

  THE ACCOUNT GENERATED A (B)(6) RESULT ON A DONOR WHO TESTED (B)(6), CONFIRMED (B)(6). DATA PROVIDED: DONOR 1 GENERATED (B)(6) (34.34 S/CO) AND (B)(6) CONFIRMATORY (B)(6), BUT THEN GENERATED (B)(6) (0.35 S/CO) 5 DAYS LATER. DONOR 1 WAS A FIRST TIME DONOR. THE DONOR CAN DONATE PLASMA TWICE A WEEK AND BOTH FIRST AND SECOND PLASMA DONATIONS ARE HELD UNTIL THE RESULTS FROM THE FIRST DONATION WERE REPORTED. DONOR 1 WAS THEN INDEPENDENTLY DIAGNOSED WITH (B)(6) BY A PHYSICIAN AND BELIEVED TO BE TRULY (B)(6). NO PLASMA UNITS WERE RELEASED FOR USE AND THE DONOR IS DEFERRED FROM FURTHER DONATION. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED. NO SPECIFIC DONOR INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431790 ↗
• MalfunctionApr 11, 2018False Positive Result; False Positive Result

  THE ACCOUNT STATED A DONOR GENERATED (B)(6) PRISM HBSAG (B)(6), CONFIRMED (B)(6) WITH PRISM HBSAG CONFIRMATORY RESULTS. DATA PROVIDED: DONOR 2 GENERATED PRISM HBSAG (B)(6)) AND CONFIRMED (B)(6) CONFIRMATORY (B)(6) USING A DIFFERENT SAMPLE FROM THE SAME DRAW. A SECOND BLOOD DRAW GENERATED (B)(6) PRISM HBSAG RESULTS. NO PLASMA UNITS WERE RELEASED FOR USE AND THE DONOR IS DEFERRED FROM FURTHER DONATION. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED. NO SPECIFIC DONOR INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423594 ↗
• MalfunctionMar 31, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTS THAT DONOR SAMPLE (B)(6) GENERATED REPEAT (B)(6) RESULTS WITH THE ABBOTT PRISM HBSAG ASSAY LOT 80049M500 WHEN TESTED ON ABBOTT PRISM SERIAL NUMBER (B)(4). THIS SAME SAMPLE HAD GENERATED AN INITIAL (B)(6) RESULT ON ABBOTT PRISM SERIAL NUMBER (B)(4) WITH THE SAME REAGENT LOT. THE CUSTOMER DOES NOT PERFORM CONFIRMATORY TESTING AT THEIR FACILITY. THE SAMPLE WAS THEREFORE SENT TO ANOTHER LAB AND TESTED WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY AND WAS CONFIRMED (B)(6). THE SAME SAMPLE TESTED (B)(6)WITH AN NAT PROCEDURE. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7387622 ↗
• MalfunctionMar 31, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTS THAT ANOTHER LAB SENDS THEM THEIR REPEAT (B)(6) SAMPLES FOR CONFIRMATORY NEUTRALIZATION TESTING WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY. ON (B)(6) 2018, SAMPLE (B)(6) THAT GENERATED REPEAT (B)(6) RESULTS AT THE OTHER LAB GENERATED CONFIRMATORY NEUTRALIZATION ASSAY RESULTS OF (B)(6) WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY. THE SAMPLE TESTED (B)(6) BY A (B)(6) NAT METHOD AND WAS (B)(6). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7387619 ↗
• MalfunctionMar 31, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTS THAT DONOR SAMPLES (B)(6) GENERATED INITIAL AND REPEAT (B)(6) RESULTS WITH THE ABBOTT PRISM HBSAG ASSAY REAGENT LOT 81091M500 ON THE ABBOTT PRISM ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER DOES NOT PERFORM CONFIRMATORY TESTING AT THEIR FACILITY. THE SAMPLES WERE THEREFORE SENT TO ANOTHER LAB AND TESTED WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY AND WERE CONFIRMED (B)(6). THE SAME SAMPLES TESTED (B)(6) WITH AN NAT PROCEDURE. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7387577 ↗
• MalfunctionMar 31, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTS THAT ANOTHER LAB SENDS THEM THEIR REPEAT REACTIVE HBSAG SAMPLES FOR CONFIRMATORY NEUTRALIZATION TESTING WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY. ON (B)(6) 2018, SAMPLES (B)(6) THAT GENERATED REPEAT (B)(6) RESULTS AT THE OTHER LAB GENERATED CONFIRMATORY NEUTRALIZATION ASSAY RESULTS OF (B)(6) WITH THE ABBOTT PRISM HBSAG CONFIRMATORY ASSAY. BOTH SAMPLES TESTED (B)(6) BY A (B)(6) NAT METHOD AND WERE (B)(6). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO DONOR MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7387566 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) RESULT. THE PLASMA DONATION SAMPLE (B)(6) WAS (B)(6). HOWEVER, THE SAMPLE WAS (B)(6) WITH THE ROCHE NAT ASSAY. THE CUSTOMER FURTHER INDICATED THE DONOR WAS (B)(6) PRIOR TO THE (B)(6) RESULT AND THE SUBSEQUENT DONATION (2 TO 4 DAYS LATER) WAS ALSO (B)(6). NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221540 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED MULTIPLE (B)(6) ABBOTT PRISM HBSAG RESULTS. TWO PLASMA DONATION SAMPLES WERE (B)(6) PRISM HBSAG AND CONFIRMED (B)(6) BY THE PRISM HBSAG CONFIRMATORY ASSAY. HOWEVER, THE SAMPLES WERE (B)(6) WITH THE ROCHE NAT ASSAY. THE CUSTOMER FURTHER INDICATED EACH DONOR WAS (B)(6) PRIOR TO THE (B)(6) RESULT AND THE SUBSEQUENT DONATION (2 TO 4 DAYS LATER) WERE ALSO (B)(6) FOR (B)(6). NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO DONOR MANAGEMENT WAS REPORTED. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221517 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED MULTIPLE (B)(6) RESULTS. THREE PLASMA DONATION SAMPLES WERE REPEAT (B)(6) FOR PRISM HBSAG AND CONFIRMED (B)(6) BY THE PRISM HBSAG CONFIRMATORY ASSAY. HOWEVER, THE SAMPLES WERE (B)(6) WITH THE ROCHE NAT ASSAY. THE CUSTOMER FURTHER INDICATED EACH DONOR WAS (B)(6) PRIOR TO THE (B)(6) RESULT AND THE SUBSEQUENT DONATION (2 TO 4 DAYS LATER) WERE ALSO (B)(6). NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO DONOR MANAGEMENT WAS REPORTED. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221510 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ABBOTT PRISM HBSAG RESULT. THE PLASMA DONATION SAMPLE ((B)(6)) WAS (B)(6) FOR PRISM (B)(6) AND CONFIRMED (B)(6) BY THE PRISM HBSAG CONFIRMATORY ASSAY. THE CUSTOMER FURTHER INDICATED THE DONOR WAS (B)(6) PRIOR TO THE (B)(6) RESULT AND THE SUBSEQUENT DONATION (2 TO 4 DAYS LATER) WAS ALSO (B)(6) FOR (B)(6). NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221487 ↗
• MalfunctionMay 10, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A DONOR UNIT THAT WAS COLLECTED ON (B)(6) 2016 GENERATED A FALSE NONREACTIVE (0.61 S/CO) ABBOTT PRISM HBSAG RESULT. THE CUSTOMER INDICATED THE DONOR UNIT GENERATED ULTRIO NAT POSITIVE (16.8 UNIT OF MEASURE NOT PROVIDED). WHEN SEPARATED OUT FOR INDIVIDUAL TESTING, (B)(6) WERE NEGATIVE AND (B)(6) WAS (B)(6) (23.87 UNIT OF MEASURE NOT PROVIDED). THE CUSTOMER FURTHER INDICATED THE NONREACTIVE 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 6559249 ↗
• MalfunctionFeb 21, 2017False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT SUSPECTED (B)(6) RESULTS WERE GENERATED. A SAMPLE WAS INITIALLY TESTED ON (B)(6) 2016 AND A REACTIVE RESULT OF 1.04 S/CO WAS GENERATED. THE SAMPLE WAS REPEATED IN DUPLICATE AND REACTIVE RESULTS OF 1.17 AND 1.14 S/CO WERE GENERATED. PRISM HBSAG CONFIRMATORY TESTING WAS PERFORMED ON (B)(6) 2017 AND A NON-CONFIRMING RESULT WAS GENERATED WITH A S/CO OF 1.44 AND A % NEUTRALIZATION OF -30.17. THE CUSTOMER INADVERTENTLY PERFORMED CONFIRMATORY TESTING AGAIN ON (B)(6) 2017 AND A CONFIRMED POSITIVE RESULT WAS GENERATED WITH A S/CO OF 2.29 AND A % NEUTRALIZATION OF 67.03. NO FURTHER TESTING WAS PERFORMED ON THE SAMPLE. THE SAMPLE WAS FROM A FIRST TIME DONOR THAT HAD RECEIVED THE (B)(6) VACCINATION 18 MONTHS PRIOR. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6347244 ↗