ABBOTT PRISM 7K35-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380740062941), received between Nov 15, 2016 and Jul 6, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (9 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 18 most recent of 18 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 25, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN INCREASE IN FALSE REPEAT REACTIVE PRISM CHAGAS RESULTS ON MULTIPLE DONORS THAT DID NOT CONFIRM BY ESA CHAGAS CONFIRMATORY TESTING. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9369294 ↗
• MalfunctionFeb 15, 2019False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ABBOTT PRISM CHAGAS RESULTS. SAMPLE ID (B)(6) : (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY SAMPLE ID (B)(6): (B)(6) YEAR OLD MALE, PRISM CHAGAS REPEAT REACTIVE AND NEGATIVE ON CHAGAS ORTHO SUMMIT ASSAY NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344022 ↗
• MalfunctionAug 28, 2018False Negative Result; False Negative Result

  DURING A CLINICAL EVALUATION STUDY USING PRISM CHAGAS 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. TWO FALSE NON-REACTIVE SAMPLES ON THE PRISM CHAGAS ASSAY FOR SAMPLES W14091712737300 AND W14091801031634 WERE IDENTIFIED DURING THE COURSE OF THE STUDY. 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 7824143 ↗
• MalfunctionJul 23, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED MULTIPLE FALSELY REACTIVE RESULTS WHILE USING THE PRISM CHAGAS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID NUMBERS WERE PROVIDED AND THE CUSTOMER STATED REPEAT REACTIVE SPECIMENS DID NOT CONFIRM (CONFIRMATORY TESTING NEGATIVE), HOWEVER SPECIFIC RESULTS VALUES WERE NOT PROVIDED. (B)(6). NO IMPACT TO PATIENT OR DONOR MANAGEMENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711415 ↗
• MalfunctionJul 23, 2018False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED MULTIPLE FALSELY REACTIVE RESULTS WHILE USING THE PRISM CHAGAS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID NUMBERS WERE PROVIDED AND THE CUSTOMER STATED REPEAT REACTIVE SPECIMENS DID NOT CONFIRM (CONFIRMATORY TESTING NEGATIVE), HOWEVER SPECIFIC RESULTS VALUES WERE NOT PROVIDED. (B)(4). NO IMPACT TO PATIENT OR DONOR MANAGEMENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711411 ↗
• MalfunctionMay 26, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED A BLOOD DONOR WHO TESTED REACTIVE FOR PRISM ANTI-T.CRUZI AND WAS ESA CHAGAS POSITIVE. THE SAMPLE WAS SENT FOR FOLLOW-UP TESTING BY THE CDC FOR T.CRUZI AB EIA AND T.CRUZI AB IB (TESA) WHICH WERE BOTH NEGATIVE. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6594069 ↗
• MalfunctionMay 24, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED INCREASE IN (B)(6) PRISM CHAGAS AND PRISM HCV RESULTS IN (B)(6)2017. OF 14 RR CHAGAS SAMPLES 7 WERE (B)(6). SUPPLEMENTAL/CONFIRMATORY TESTING WAS PERFORMED WITH ORTHO CHAGAS (2 (B)(6), 5 NOT TESTED); ORTHO HCV ALL 7 (B)(6); ABBOTT CHAGAS ESA (6 (B)(6), ONE NOT TESTED). THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6587614 ↗
• MalfunctionMar 24, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY REACTIVE CHAGAS BLOOD DONOR SPECIMENS WHILE USING PRISM CHAGAS REAGENTS. THE SPECIMEN RESULTS WERE REPEAT REACTIVE USING THE PRISM REAGENTS, HOWEVER DID NOT CONFIRM. THE FOLLOWING DATA WAS PROVIDED (S/CO): CHAGAS TESTS: SID (B)(6) INITIAL 3.47 (REACTIVE), REPEAT 3.69, 3.86 (REACTIVE), SID (B)(6) INITIAL 4.64 (REACTIVE), REPEAT 5.16, 4.48 (REACTIVE), SID (B)(6) INITIAL 2.64 (REACTIVE), REPEAT 2.49, 2.93 (REACTIVE), SID (B)(6) INITIAL 4.92 (REACTIVE), REPEAT 4.37, 5.16 (REACTIVE). NO SPECIFIC VALUES WERE PROVIDED FOR SID (B)(6). ALL THE UNITS WERE T. CRUZI (CHAGAS) NEGATIVE USING A SUPPLEMENTAL METHOD, WITH THE EXCEPTION OF SID (B)(6) THAT RETURNED AN INTERMEDIATE RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6433860 ↗
• MalfunctionMar 17, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CHAGAS RESULTS ON THE PRISM ANALYZER. NO SPECIFIC INITIAL AND REPEAT DATA WAS PROVIDED FOR THE FOLLOWING SID'S: (B)(6) AND 4 MORE SAMPLES WITH NO SID PROVIDED. THE CUSTOMER OBSERVED SAMPLES THAT WERE REPEAT REACTIVES ON THE DUPLICATE RETEST ON CHAGAS, WHICH DID NOT CONFIRM BY AN ALTERNATE METHOD/SUPPLEMENTAL TEST (TEST DATE (B)(6) 2017). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED, HOWEVER THE 13 BLOOD DONORS WERE DEFERRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6414921 ↗
• MalfunctionNov 21, 2016False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE REPEATEDLY REACTIVE PRISM CHAGAS RESULTS ON 20 DONORS THAT TESTED ESA CHAGAS NEGATIVE SINCE (B)(6) 2016. ADDITIONALLY, 5 DONORS WERE PRISM CHAGAS WERE REPEATEDLY REACTIVE BUT NO CONFIRMATORY TESTING WAS AVAILABLE SINCE JANUARY 2016. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC DONOR INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118950 ↗
• MalfunctionNov 21, 2016False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE REPEATEDLY REACTIVE PRISM CHAGAS RESULTS ON 20 DONORS THAT TESTED ESA CHAGAS NEGATIVE SINCE MAY 2016. ADDITIONALLY, 5 DONORS WERE PRISM CHAGAS WERE REPEATEDLY REACTIVE BUT NO CONFIRMATORY TESTING WAS AVAILABLE SINCE JANUARY 2016. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC DONOR INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118917 ↗
• MalfunctionNov 15, 2016High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER INDICATED AN INCREASE IN REACTIVE RESULTS HAS BEEN GENERATED WHILE USING THE PRISM CHAGAS ASSAY ON THE PRISM 6 CHANNEL ANALYZER. DURING THE TIMEFRAME OF (B)(6) 2016 TO (B)(6) 2016, TWELVE SPECIMENS WHICH HAD BEEN REPEAT REACTIVE WERE NEGATIVE WHEN TESTED USING THE ORTHO METHOD. NO SPECIFIC PATIENT DATA HAS BEEN PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6103040 ↗
• MalfunctionNov 15, 2016High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER INDICATED AN INCREASE IN REACTIVE RESULTS HAS BEEN GENERATED WHILE USING THE PRISM CHAGAS ASSAY ON THE PRISM 6 CHANNEL ANALYZER. DURING THE TIMEFRAME OF (B)(6) 2016, TWELVE SPECIMENS WHICH HAD BEEN REPEAT REACTIVE WERE NEGATIVE WHEN TESTED USING THE ORTHO METHOD. SPECIFICALLY THE CUSTOMER INDICATED THAT A FALSE POSITIVE RESULT WAS GENERATED ON (B)(6) 2016 USING LOT 61004M500. NO SPECIFIC PATIENT DATA HAS BEEN PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6103039 ↗
• MalfunctionNov 15, 2016High Test Results; High Test Results

  THE CUSTOMER INDICATED AN INCREASE IN REACTIVE RESULTS HAS BEEN GENERATED WHILE USING THE PRISM CHAGAS ASSAY ON THE PRISM 6 CHANNEL ANALYZER. DURING THE TIMEFRAME OF (B)(6) 2016 TO (B)(6) 2016, TWELVE SPECIMENS WHICH HAD BEEN REPEAT REACTIVE WERE NEGATIVE WHEN TESTED USING THE ORTHO METHOD. SPECIFICALLY THE CUSTOMER INDICATED THAT FALSE POSITIVE RESULTS WERE GENERATED ON (B)(6) 2016 AND (B)(6) 2016 USING LOT 60017M500. NO SPECIFIC PATIENT DATA HAS BEEN PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6103038 ↗