ABBOTT PRISM 3L68-68Recalls & reported problems
Abbott Laboratories · ABBOTT PRISM HIV O Plus Assay Kit
Quick summary
This Abbott PRISM HIV O Plus assay kit is a laboratory test kit used to screen donated blood for HIV. The 47 reports mostly describe the analyzer producing reactive or false positive HIV results on donor samples that later testing did not confirm, along with calibration errors. There are no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00380740062958), received between Mar 3, 2017 and Oct 5, 2021 — classified as 1 injury, 46 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (26 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
Device problems
- False Positive Result26
- Calibration Error13
- High Test Results5
- Failure to Calibrate1
- False Negative Result1
- Low Test Results1
Patient problems
- No Known Impact Or Consequence To Patient28
- No Patient Involvement14
- No Consequences Or Impact To Patient3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2021False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS FOR ONE DONOR ON (B)(6) 2021. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT ON SN (B)(6) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576751 ↗MalfunctionJan 10, 2020False Positive Result; False Positive Result
THE CUSTOMER REPORTED AN INCREASE IN REACTIVE RATES FOR (B)(6) RESULTS WHEN PROCESSING ON THE PRISM. SAMPLES WERE RETESTED IN DUPLICATE AND THE RESULTS WERE REACTIVE. THE CUSTOMER STATED CONFIRMATORY TESTING WAS NONREACTIVE. ADDITIONAL TESTING WITH WESTERN BLOT AND (B)(6) EIA WAS ALSO NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9573678 ↗MalfunctionDec 17, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED AN INCREASE IN (B)(6) RATES FOR (B)(6) RESULTS WHEN PROCESSING ON THE PRISM. SAMPLES WERE RETESTED IN DUPLICATE AND THE RESULTS WERE (B)(6). THE CUSTOMER STATED CONFIRMATORY TESTING WAS (B)(6). ADDITIONAL TESTING WITH WESTERN BLOT AND HIV-2 EIA WAS ALSO (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9485071 ↗MalfunctionDec 17, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED (B)(6) PRISM HIV RESULTS ON 4 DONORS. THE RESULTS PROVIDED WERE: (B)(6) 2019 UNIT (B)(6) = (B)(6); ON (B)(6) 2019 UNIT (B)(6) = (B)(6); ON (B)(6) 2019 UNIT (B)(6) = (B)(6) / ON (B)(6) 2019 UNIT (B)(6) = (B)(6). ALL FOUR SAMPLES WERE NOT CONFIRMED WITH WESTERN BLOT. THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9482666 ↗MalfunctionDec 17, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED (B)(6) PRISM HIV RESULTS ON 4 DONORS. THE RESULTS PROVIDED WERE: (B)(6) 2019 UNIT (B)(6) = 1(B)(6); ON (B)(6) 2019 UNIT (B)(6) = (B)(6); ON (B)(6) 2019 UNIT (B)(6) = (B)(6). ON (B)(6) 2019 UNIT (B)(6) = (B)(6). ALL FOUR SAMPLES WERE NOT CONFIRMED WITH WESTERN BLOT. THERE WAS NO REPORTED IMPACT TO DONOR/PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9482642 ↗MalfunctionDec 12, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE POSITIVE HIV RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT REACTIVE AND CONFIRMED NEGATIVE ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9460849 ↗MalfunctionDec 12, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9460834 ↗MalfunctionDec 12, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9460832 ↗MalfunctionDec 12, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9460809 ↗MalfunctionDec 12, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9460783 ↗MalfunctionNov 20, 2019False Positive Result; False Positive Result
THE CUSTOMER OBSERVED FALSE (B)(6) RESULTS ON THE PRISM ANALYZER. SEVENTY TWO (72) RESULTS WERE REPEAT (B)(6) AND CONFIRMED (B)(6) ON NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9346581 ↗MalfunctionNov 6, 2019False Positive Result; False Positive Result
THE CUSTOMER REPORTED A (B)(6) PRISM HIV O PLUS RESULT ON ONE DONOR. INITIAL TESTING WAS (B)(6). REPEAT RESULT PROVIDED: (B)(6) 2019 SID (B)(6) = (B)(6); SAMPLE WAS NAT TESTING (B)(6). PREVIOUS SAME DONOR TESTED ON (B)(6) 2019 SID (B)(6) WAS (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9285679 ↗MalfunctionDec 20, 2018False Positive Result; False Positive Result
THE ACCOUNT OBSERVED AN INCREASE IN (B)(6) PRISM HIV O PLUS RESULTS USING CADAVERIC SPECIMENS. FOUR CADAVERIC SPECIMENS WERE PRISM HIV O PLUS REPEATEDLY (B)(6) BUT CONFIRMED (B)(6) BY A REFERENCE LAB. (B)(6). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8183457 ↗MalfunctionDec 20, 2018False Positive Result; False Positive Result
THE ACCOUNT OBSERVED AN INCREASE IN (B)(6) PRISM HIV O PLUS RESULTS USING CADAVERIC SPECIMENS. FOUR CADAVERIC SPECIMENS WERE PRISM HIV O PLUS REPEATEDLY (B)(6) BUT CONFIRMED (B)(6) BY A REFERENCE LAB. (B)(6). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8183454 ↗MalfunctionOct 24, 2018Failure to Calibrate; Failure to Calibrate
THE CUSTOMER WAS EXPERIENCING CALIBRATION FAILURES DUE TO (B)(6) GROUP O (B)(6) ASSAY CONTROL OUT OF RANGE HIGH WITH ABBOTT PRISM HIV O PLUS, LIST NUMBER 03L68-68 LOT 83104M500. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8000961 ↗MalfunctionOct 10, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) HIV O PLUS RESULTS ON ONE LOT AND 3 PRISM ANALYZERS. NO SPECIFIC REPEAT (B)(6) DATA WAS PROVIDED FOR THE 20 SIDS AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE SAMPLES WERE CONFIRMED (B)(6) ON (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7953354 ↗MalfunctionOct 5, 2018False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE PRISM HIV O PLUS RESULT FOR ONE SAMPLE. THE SAMPLE GENERATED NEGATIVE CONFIRMATORY RESULTS. NO ADVERSE IMPACT TO DONOR OR PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7940086 ↗MalfunctionSep 20, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE (B)(6): TESTED ON (B)(6) 2018. (B)(4) LOT 87090M500, EXP 1/9/2019. (B)(6). PER THE PACKAGE INSERT: REPEATEDLY (B)(6) RESULTS INDICATE THE PRESENCE OF (B)(6) BY THE CRITERIA OF THE ABBOTT PRISM HIV O PLUS ASSAY. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894766 ↗MalfunctionSep 20, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) HIV O PLUS RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6), TESTED ON (B)(6) 2018 ON PRISM 1238 WITH (B)(6) LOT # 87088M500, EXP 1/9/19. (B)(6). WESTERN BLOT AND NAT TESTING WERE ALSO POSITIVE. PER THE PACKAGE INSERT: REPEATEDLY REACTIVE RESULTS INDICATE THE PRESENCE OF ANTI-HIV-1 AND/OR ANTI-HIV-2 BY THE CRITERIA OF THE ABBOTT PRISM HIV O PLUS ASSAY. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894763 ↗MalfunctionSep 20, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) HIV O PLUS RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE (B)(6); TESTED ON (B)(6) 1208 ON PRISM 1267 WITH (B)(6) LOT # 88015M500, EXP 2/22/19; (B)(6). SAMPLE: (B)(6); (B)(6)ON (B)(6) 1208 AND TESTED ON PRISM1425 WITH (B)(6) LOT 87091M500; (B)(6) ON (B)(6) 2018 AND TESTED ON PRISM 1389 WITH (B)(6) LOT 88015M500; (B)(6). PER THE PACKAGE INSERT: REPEATEDLY REACTIVE RESULTS INDICATE THE PRESENCE OF ANTI-HIV-1 AND/OR ANTI-HIV-2 BY THE CRITERIA OF THE ABBOTT PRISM HIV O PLUS ASSAY. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894756 ↗MalfunctionSep 20, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE: (B)(6); INITIAL S/CO = 63.91 ON (B)(6) 2018 AND TESTED ON PRISM 1425 WITH (B)(6) LOT 87091M500; REPEAT S/CO = 11.31, 104.19 ON (B)(6) 2018 AND TESTED ON PRISM 1389 WITH (B)(6) LOT 88015M500; WESTERN BLOT TESTING WAS POS. SAMPLE: (B)(6) TESTED ON (B)(6) 2018. (B)(6) LOT # 87091M500; INITIAL S/CO = 1.29 AND TESTED ON PRISM 1342; REPEAT S/CO = 1.46,1.29 ON PRISM 1342; WESTERN BLOT TESTING WAS (B)(6). NAT TESTING WAS (B)(6). SAMPLE: (B)(6) TESTED ON (B)(6) 2018. (B)(6) LOT # 87091M500; INITIAL S/CO = 1.22 AND TESTED ON PRISM 1424; REPEAT S/CO = 1.18, 1.24 AND TESTED ON PRISM 1425; WESTERN BLOT TESTING WAS (B)(6). SAMPLE: (B)(6); (B)(6) LOT # 87091M500; INITIAL S/CO = 1.14 AND TESTED ON PRISM 1425 ON (B)(6) 2018; REPEAT S/CO = 1.17, 1.26 ON PRISM 1421 ON (B)(6) 2018; WESTERN BLOT TESTING WAS (B)(6). NAT TESTING WAS (B)(6). SAMPLE: (B)(6); (B)(6) LOT # 87091M500; INITIAL S/CO = 1.26 AND TESTED ON PRISM 1425 ON (B)(6) 2018; REPEAT S/CO = 1.28, 1.23 ON PRISM 1421 ON (B)(6) 2018; WESTERN BLOT TESTING WAS (B)(6). SAMPLE: (B)(6); (B)(6) LOT # 87091M500; INITIAL S/CO = 99.05 ON (B)(6) 2018 AND
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894754 ↗MalfunctionSep 20, 2018False Positive Result; False Positive Result
THE CUSTOMER OBSERVED (B)(6) HIV O PLUS RESULTS ON THE PRISM ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE: (B)(6), TESTED ON (B)(6) 2018. HIV LOT # 87089M500, (B)(6) AND TESTED ON PRISM (B)(4), REPEAT (B)(6) AND TESTED ON PRISM (B)(4), (B)(6) TESTING WAS (B)(6). PER THE PACKAGE INSERT: REPEATEDLY REACTIVE RESULTS INDICATE THE PRESENCE OF ANTI-HIV-1 AND/OR ANTI-HIV-2 BY THE CRITERIA OF THE ABBOTT PRISM HIV O PLUS ASSAY. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894750 ↗MalfunctionSep 17, 2018False Positive Result; False Positive Result
THE CUSTOMER EXPERIENCED MULTIPLE (B)(6) RESULTS AND AN INCREASE IN (B)(6) RATES WHILE USING PRISM HIV O PLUS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (TESTED (B)(6) 2018) INITIAL (USING ANALYZER SN (B)(4)) (B)(6)), REPEAT (USING ANALYZER SN (B)(4)) (B)(6)), WESTERN BLOT TESTING WAS (B)(6). NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7882571 ↗MalfunctionSep 17, 2018False Positive Result; False Positive Result
THE CUSTOMER EXPERIENCED MULTIPLE (B)(6) RESULTS AND AN INCREASE IN (B)(6) RATES WHILE USING PRISM HIV O PLUS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (TESTED (B)(6) 2018 USING ANALYZER SN (B)(4)) INITIAL (B)(6), REPEAT (B)(6), WESTERN BLOT AND NAT TESTING WERE (B)(6). SID (B)(6) (TESTED (B)(6) 2018) INITIAL (USING ANALYZER SN (B)(4)) (B)(6), REPEAT (USING ANALYZER SN (B)(4)) (B)(6), WESTERN BLOT TESTING WAS (B)(6). SID (B)(6) INITIAL (TESTED (B)(6) 2018 USING ANALYZER SN (B)(4)) (B)(6), REPEAT (TESTED (B)(6) 2018 USING ANALYZER SN (B)(4)) (B)(6), WESTERN BLOT AND NAT TESTING WERE (B)(6). SID (B)(6) INITIAL (TESTED (B)(6) 2018 USING ANALYZER SN (B)(4)) (B)(6), REPEAT (TESTED JULY 29, 2018 USING ANALYZER SN (B)(4)) (B)(6), WESTERN BLOT TESTING WAS (B)(6). NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7882569 ↗MalfunctionSep 17, 2018False Positive Result; False Positive Result
THE CUSTOMER EXPERIENCED MULTIPLE FALSELY REACTIVE RESULTS AND AN INCREASE IN REACTIVE RATES WHILE USING PRISM HIV O PLUS REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) (TESTED (B)(6) 2018 USING ANALYZER SN (B)(4) INITIAL 1.44 S/CO (REACTIVE), REPEAT 1.41, 1.56 S/CO (REACTIVE), WESTERN BLOT TESTING WAS NEGATIVE. NO IMPACT TO PATIENT OR DONOR MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7882567 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.