GS 25256Recalls & reported problems
Bio-RAD Laboratories, Inc. · Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PLUS O EIA 4800 Test Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847865001953), received between Oct 14, 2019 and Oct 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Test Result1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON SEPTEMBER 19, 2019 BIO-RAD TECHNICAL SUPPORT RECEIVED A COMPLAINT FORWARDED FROM A DISTRIBUTION PARTNER ABOUT AN INCIDENT THAT HAPPENED AT CUSTOMER FACILITY. THE INITIAL COMPLAINT WAS FOR AN INCREASE IN INITIALLY REACTIVE (IR) RESULTS THAT DID NOT REPEAT IN SECONDARY TESTING USING THE BIO-RAD GS HIV-1/HIV-2 PLUS O ASSAY. AFTER A PRELIMINARY INVESTIGATION IT WAS FOUND THAT THE IR RESULTS IN QUESTION ALL CAME FROM ONE PLATE RUN ON (B)(6) 2019. FURTHER INVESTIGATION INTO THE ISSUE REVEALED THAT THE RESULTS IN QUESTION WERE DONOR SAMPLES THAT WERE, DUE TO USER ERROR, INADVERTENTLY RUN IN NULL STRIPS IN ROWS 9-12 ON THE TEST PLATE. THE CUSTOMER'S PRACTICE IS TO USE PREVIOUSLY TESTED STRIPS THAT HAVE BEEN CLEANED AS NULL STRIPS. PREVIOUSLY USED STRIPS ARE MARKED WITH A BLACK LINE ACROSS THE BOTTOM OF THE STRIP TO INDICATE THEM AS NULL. THE PACKAGE INSERT STATES THAT THE OPERATOR SHOULD "TAKE CARE WHEN ASSEMBLING PARTIAL PLATES WITH COATED AND UNCOATED (NULL) STRIPS, AS AUTOMATED SYSTEMS CANNOT DISTINGUISH BETWEEN THE STRIPS AND WILL REPORT RESULTS FOR ALL WELLS THAT ARE ASSIGNED A SAMPLE ID NUMBER (EVEN IF A NULL STRIP IS INADVERTENTLY PLACED WHERE SAMPLE IDS HAVE BEEN ASSIGNED)." IT
Patient problems: Test Result
MAUDE report 9187846 ↗
Other Test, Hiv Detection devices
- Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection409 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection238 reports
- Elecsys HIV Duo 08836973190Roche Diagnostics GmbH · Test, HIV detection105 reports
- ARCHITECT 2P36-01Abbott GmbH · Test, hiv detection1 recall0 reports
- cobas® HIV-1 09040803190Roche Molecular Systems, Inc. · Test, HIV detection27 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Alere Scarborough, Inc. · Test, Hiv Detection27 reports
- VITROS 6842781Ortho Clinical Diagnostics · Test, hiv detection16 reports
- RealTime 6L18-90Abbott Molecular Inc. · Test, hiv detection12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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