ABBOTT PRISM 6E50-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380740063016), received between Nov 8, 2017 and Jan 6, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• 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 ↗
• 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 ↗
• MalfunctionNov 6, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE PRISM HTLV I/HTLV II RESULT ON ONE DONOR. INITIAL TESTING WAS REACTIVE. REPEAT RESULT PROVIDED: (B)(6) 2019 SID (B)(6) = 1.34 S/CO; SAMPLE WAS NAT AND WESTERN BLOT NEGATIVE. PREVIOUS SAME DONOR TESTED ON (B)(6) 2019 SID (B)(6) WAS NONREACTIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9285676 ↗
• MalfunctionOct 9, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) PRISM HTLV RESULTS FOR 15 SAMPLES USING 2 LOTS AND 5 ANALYZERS. NO SPECIFIC INITIAL AND REPEAT PRISM DATA WAS PROVIDED, THE FOLLOWING SAMPLES WERE FOUND (B)(6) ON WESTERN BLOT: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949055 ↗
• MalfunctionOct 9, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE (B)(6) PRISM HTLV RESULTS FOR 15 SAMPLES USING 2 LOTS AND 5 ANALYZERS. NO SPECIFIC INITIAL AND REPEAT PRISM DATA WAS PROVIDED, THE FOLLOWING SAMPLES WERE FOUND (B)(6) ON WESTERN BLOT: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949050 ↗
• MalfunctionMar 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THEY HAVE SEEN AN INCREASE IN REPEAT REACTIVE PRISM HTLV I/II RESULTS. UPON PERFORMING CONFIRMATORY TESTING WITH ANOTHER METHOD THE RESULTS ARE NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA OR STATE HOW MANY SAMPLES WERE INVOLVED. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375129 ↗
• MalfunctionMar 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THEY HAVE SEEN AN INCREASE IN REPEAT REACTIVE PRISM HTLV I/II RESULTS. UPON PERFORMING CONFIRMATORY TESTING WITH ANOTHER METHOD THE RESULTS ARE NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA OR STATE HOW MANY SAMPLES WERE INVOLVED. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375107 ↗
• MalfunctionMar 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THEY HAVE SEEN AN INCREASE IN REPEAT REACTIVE PRISM HTLV I/II RESULTS. UPON PERFORMING CONFIRMATORY TESTING WITH ANOTHER METHOD THE RESULTS ARE NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA OR STATE HOW MANY SAMPLES WERE INVOLVED. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375099 ↗
• MalfunctionMar 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THEY HAVE SEEN AN INCREASE IN REPEAT REACTIVE PRISM HTLV I/II RESULTS. UPON PERFORMING CONFIRMATORY TESTING WITH ANOTHER METHOD THE RESULTS ARE NEGATIVE. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA OR STATE HOW MANY SAMPLES WERE INVOLVED. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375093 ↗
• MalfunctionMar 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT THEY HAVE SEEN AN INCREASE IN REPEAT REACTIVE PRISM HTLV I/II RESULTS. UPON PERFORMING CONFIRMATORY TESTING WITH ANOTHER METHOD THE RESULTS ARE (B)(6). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC DATA OR STATE HOW MANY SAMPLES WERE INVOLVED. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374929 ↗
• MalfunctionNov 8, 2017False Negative Result; False Negative Result

  THE ACCOUNT GENERATED A FALSE NEGATIVE PRISM HTLV-I/II (0.26 S/CO) RESULT ON A SERUM SAMPLE. THE PLASMA SAMPLE FROM THE DONOR GENERATED REACTIVE PRISM HTLV-I/II RESULTS ON ANOTHER ANALYZER. THE BLOOD PRODUCTS FROM THE DONATION WERE NOT RELEASED AND WERE DESTROYED. NO SPECIFIC DONOR INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7009586 ↗