ABBOTT PRISM 6A36-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740008420), received between Dec 4, 2017 and Oct 8, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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.

• MalfunctionOct 8, 2019False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE (B)(6) PRISM HIV O PLUS RESULTS FOR SEVERAL SAMPLES. DURING THE WEEK OF (B)(6) 2019 39 (B)(6) RESULTS WERE GENERATED. CONFIRMATORY TESTING USING WESTERN BLOT AND EIA CONFIRMED 26 OF THE 39 SAMPLES WERE (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168374 ↗
• MalfunctionJul 10, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY REPEAT REACTIVE PRISM ANTI-HCV RESULTS ON MULTIPLE DONORS. INITIAL AND REPEAT REACTIVE RATES FOR THE ANTI-HCV ASSAY INCREASED THE WEEK ENDING 15JUN2019 AND CONTINUED THROUGH THE WEEK ENDING 22JUN2019. HISTORICALLY, HCV REPEAT REACTIVE RATES RUN 0.04% OF TOTAL DONORS TESTED, WITH MORE THAN 50% CONFIRMING BY SUPPLEMENTAL DHCV TESTING. DURING THE TWO WEEKS NAMED ABOVE, HCV REPEAT REACTIVE RATES WERE 0.07% OF TOTAL DONORS TESTED, WITH ONLY 30% CONFIRMING. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776958 ↗
• MalfunctionJul 8, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED AN INCREASE IN INITIAL REACTIVE PRISM HCV RESULTS WITH A NEW REACTION TRAY LOT 03018M700. BETWEEN 07JUN2019 AND 11JUN2019 THE CUSTOMER HAD 52 INITIAL REACTIVE HCV RESULTS THAT WHEN RETESTED WITH THEIR CURRENT TRAY LOT 03015M700, 23 WERE REPEAT REACTIVE. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8769071 ↗
• InjuryDec 4, 2017Use of Device Problem; Use of Device Problem

  THE ACCOUNT STATED AN EMPLOYEE'S EYE WAS SPLASHED WITH A02 CONTROL. THE OPERATOR WAS PREPARING VALIDATION SAMPLES BY INJECTING A02 CONTROL INTO TUBES TO BE PLACED ON THE PRISM ANALYZER. A TECHNICIAN WAS STANDING CLOSE BY AND GOT SPLASHED IN THE EYE. THE TECHNICIAN WAS NOT WEARING EYE PROTECTION AND RINSED EYES FOR 15 MINUTES. THE TECHNICIAN IS PREVENTATIVELY TAKING DOLUTEGRAVIR AND EMITRICITABINE -TENOFOVIR AND IS DOING OK.

  Patient problems: Eye Injury

  MAUDE report 7081819 ↗