GS 26217Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847865010658), received between Aug 18, 2016 and May 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “False Positive Result” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2018False Positive Result

  BIO-RAD TECHNICAL SUPPORT WAS CONTACTED BY (B)(6) HOSPITAL ON 4/12/2018, TO REPORT THAT ON (B)(6) 2018 A PATIENT SAMPLE WAS TESTED WITH GS HIV COMBO AG/AB EIA (LOT 159MJJ-02, EXP. 06/08/2018), WHICH GAVE AN INITIAL (B)(6). THE SAMPLE WAS THEN REPEATED ON (B)(6) 2018 IN DUPLICATE WITH GS HIV COMBO AG/AB EIA (LOT 159MJJ-02, EXP. 06/08/2018); BOTH RESULTS WERE (B)(6). THE INITIAL SAMPLE WAS ALSO TESTED ON (B)(6) 2018 ON THE GEENIUS WHICH SHOWED (B)(6) PRESENT, (B)(6) AS THE FINAL INTERPRETATION. THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE PSYCHIATRIC UNIT DUE TO HER REACTION AFTER RECEIVING THE INITIAL (B)(6) TEST RESULTS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT IS/HAS BEEN A PSYCHIATRIC PATIENT. THE PATIENT REQUESTED A RETEST, AND WAS REDRAWN ON (B)(6) 2018. THE RESULTS FOR THE SECOND SAMPLE FOR GS HIV COMBO AG/AB EIA (LOT 101NJJ-02, EXP. 01/12/2018) GAVE (B)(6) RESULTS. THE CUSTOMER HAD A THIRD SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2018, WITH A PSEUDO CHAIN OF CUSTODY. THE RESULTS FOR THE THIRD SAMPLE FOR GS HIV COMBO AG/AB EIA (LOT 101NJJ-02, EXP. 01/12/2018) GAVE (B)(6) RESULTS. NAT TESTING WAS PERFORMED ON THE SECOND AND THIRD SAMPLES COLLECTED FROM THE P

  Patient problems: Emotional Changes

  MAUDE report 7504774 ↗
• Aug 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SERVICES AND IT WAS DISCOVERED THAT THEY ARE NOT FOLLOWING THE PACKAGE INSERT FOR (B)(6) WITH REGARD TO APPROVED SAMPLE TYPE. THE CUSTOMER IS RUNNING WHOLE BLOOD SAMPLES ON THE ASSAY, WHERE THE ASSAY DOES NOT HAVE A WHOLE BLOOD CLAIM. THE ASSAY IS APPROVED ONLY FOR SERUM OR PLASMA SAMPLES. THERE IS ALSO CONCERN THAT THE CUSTOMER DOES NOT APPEAR TO BE FOLLOWING STANDARD CLSI GP44-A4 SAMPLE HANDLING REQUIREMENTS TO SEPARATE THE SAMPLE FROM THE CLOT AS SOON AS POSSIBLE IN ORDER TO PRESERVE MAXIMUM P24 ANTIGEN REACTIVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5886547 ↗