cobas® NHP Negative Control Kit 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00875197005127), received between Sep 18, 2025 and Sep 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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 19, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED UNEXPECTED REACTIVE RESULTS FOR HIV WHEN USING THE COBAS MPX ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER REPORTED TWO SAMPLES THAT WERE INITIALLY REACTIVE FOR HIV WITH CYCLE THRESHOLD (CT) VALUES OF 39.1 AND 42.2. THE HIV GROWTH CURVE FOR BOTH SAMPLES SHOWED LATE AND MINIMAL AMPLIFICATION. SEROLOGY TESTING FOR BOTH SAMPLES WAS NON-REACTIVE. THE COBAS MPX ASSAY WAS REPEATED ON THE SAME SAMPLES, AND THE RESULTS WERE NON-REACTIVE. THE SAMPLES WERE REPORTED AS REACTIVE, AND THE BLOOD DONATIONS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094355 ↗
• MalfunctionSep 18, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED UNEXPECTED REACTIVE RESULTS FOR HIV IN BOTH SAMPLE POOLS AND NEGATIVE CONTROLS WHEN USING THE COBAS® 6800/8800 MPX ASSAY AND KIT COBAS 6800/8800 NHP NEG RMC IVD ON THE COBAS 8800 ANALYZER. TWO SAMPLE POOLS WERE REPORTED AS REACTIVE FOR HIV. THE FIRST POOL, TESTED ON INSTRUMENT 5149 AT 06:18, HAD A CYCLE THRESHOLD (CT) VALUE OF 37.59. THE SECOND POOL, ALSO TESTED ON INSTRUMENT 5149 AT 08:36, HAD THE SAME CT VALUE OF 37.59. BOTH POOLS WERE SUBSEQUENTLY RESOLVED ON INSTRUMENT 5100. FOR THE FIRST POOL, ALL RESOLUTION TESTING WAS NON-REACTIVE. FOR THE SECOND POOL, TWO BATCHES WERE TESTED: BATCH 12606 SAMPLES WERE ALL NON-REACTIVE, AND BATCH 12608, REPEATED ON INSTRUMENT 5149, WAS ALSO NON-REACTIVE. FINAL RESOLUTION RESULTS FOR BOTH POOLS WERE NON-REACTIVE, CONSISTENT WITH NEGATIVE SEROLOGY RESULTS FOR ALL SAMPLES. THE FINAL RESULTS FOR ALL SAMPLES WERE NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086578 ↗