ABBOTT PRISM 6E51-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380740062972), received between Feb 21, 2017 and Apr 8, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  THE CUSTOMER REPORTED A FALSE (B)(6) PRISM HBSAG RESULT ON ONE DONOR. THE RESULTS PROVIDED WERE: (B)(6) HBSAG NEAT = 1.07S/CO (>/=1.00S/CO = (B)(6)) / REPEAT IN DUPLICATE = 1.11 / 1.14S/CO. THE SAMPLE HAD NEUTRALIZING CONFIRMATORY TESTING PERFORMED: 1.61S/CO(>/=1.00S/CO = (B)(6)) / RETEST = 1.57S/CO / 1:500 = 0.54S/CO (<1.00S/CO = NON(B)(6)) / 1.08S/CO; UNDILUTED 1.57S/CO % NEUT = -4.62 (PER THE PACKAGE INSERT ADDITIONAL DILUTION REQUIRED); 1:500 DILUTION 1.08S/CO % NEUT = 128.89 (CONFIRMED (B)(6)). THE SAMPLES TESTED (B)(6) FOR NAT AND (B)(6) FOR HBC. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781729 ↗
• MalfunctionSep 24, 2018False Positive Result; False Positive Result

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904081 ↗
• MalfunctionAug 21, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DONOR GENERATED (B)(6), CONFIRMED (B)(6) PRISM HBSAG RESULTS. ID (B)(6) WAS PRISM HBSAG REPEAT (B)(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 NONCONFIRMING PRISM HBSAG RESULTS. ADDITIONAL DONOR TESTING WAS (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802462 ↗
• 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), (B)(6) AND CONFIRMED HBSAG 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 7423559 ↗
• 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. 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 7387626 ↗
• 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, 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 HBSAG 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 7387615 ↗
• 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. SAMPLE IDS TESTED WITH CONFIRMATORY REAGENT LOT 75067M500: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221647 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED MULTIPLE (B)(6) PRISM HBSAG CONTIRMATORY RESULTS. TWO 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. SAMPLE IDS TESTED WITH CONFIRMATORY REAGENT LOT 76042M500: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221643 ↗
• MalfunctionJan 26, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED MULTIPLE (B)(6) CONFIRMATORY RESULTS. TWO PLASMA DONATION SAMPLES WERE REPEAT (B)(6) FOR PRISM HBSAG AND CONFIRMED (B)(6) BY THE PRISM HBSAG CONFIRMATORY ASSAY. SAMPLE ID (B)(6) WAS (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. SAMPLE IDS TESTED WITH CONFIRMATORY REAGENT LOT 73029M500: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221610 ↗
• MalfunctionFeb 21, 2017False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT SUSPECTED (B)(6) CONFIRMATORY RESULTS WERE GENERATED. A SAMPLE WAS INITIALLY TESTED WITH PRISM HBSAG ON (B)(6) 2016 AND A (B)(6) RESULT OF (B)(6) WAS GENERATED. THE SAMPLE WAS REPEATED IN DUPLICATE AND (B)(6) RESULTS OF (B)(6) WERE GENERATED. PRISM HBSAG CONFIRMATORY TESTING WAS PERFORMED ON (B)(6) 2017 AND A NONCONFIRMING RESULT WAS GENERATED WITH A (B)(6) AND A % NEUTRALIZATION OF -30.17. THE CUSTOMER INADVERTENTLY PERFORMED CONFIRMATORY TESTING AGAIN ON (B)(6) 2017 AND A CONFIRMED (B)(6) RESULT WAS GENERATED WITH A (B)(6) 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) 18 MONTHS PRIOR. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6347243 ↗