COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00875197003024), received between Sep 15, 2025 and Sep 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE RESULT USING THE KIT CAP-G/CTM HIV-1 V2.0 US-IVD ON THE COBAS AMPLIPREP INSTRUMENT. THE PATIENT, A PREGNANT WOMAN, HAD PREVIOUSLY TESTED NEGATIVE FOR HIV ON AN HIV 1/2 ANTIBODY/ANTIGEN SCREEN CONDUCTED SIX MONTHS EARLIER IN (B)(6) 2020. ON (B)(6) 2021, THE PATIENT WAS TESTED USING AN HIV 4TH GENERATION ANTIBODY/ANTIGEN RAPID SCREEN, WHICH GENERATED A PRESUMPTIVE POSITIVE RESULT. A REFLEX TEST WAS PERFORMED ON THE SAME SAMPLE USING THE HIV 1/2 DIFFERENTIAL ASSAY (BIORAD GENIUS SUPPLEMENTAL ASSAY), WHICH REPORTED A NON-REACTIVE RESULT. ON (B)(6) 2021, THE CUSTOMER CONDUCTED A POLYMERASE CHAIN REACTION (PCR) TEST USING THE KIT CAP-G/CTM HIV-1 V2.0 US-IVD, WHICH GENERATED A POSITIVE RESULT. THE POSITIVE PCR RESULT LED TO THE INITIATION OF A THREE-DRUG TREATMENT REGIMEN FOR THE PATIENT¿S NEWBORN BABY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064623 ↗
• MalfunctionSep 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST, V2.0 FOR TWO PATIENT SAMPLES ON A COBAS AMPLIPREP ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS 425 CP/ML. THE REPEAT RESULT WAS <2.00E+01CP/ML. SAMPLE 2: THE INITIAL RESULT WAS 159 CP/ML. THE REPEAT RESULT WAS TARGET NOT DETECTED. IT IS UNKNOWN IF THE SAMPLES WERE FROM SEPARATE OR THE SAME DRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057780 ↗