Elecsys HIV combi PT 05390095160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630942497), received between Jan 28, 2022 and Jan 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022False Negative Result; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS HIV COMBI PT (HIV COMBI) USING A PARTICULAR REAGENT PACK ON A COBAS 8000 E 602 MODULE. THE CUSTOMER STATED THE ISSUE BEGAN A MONTH AGO AFTER PREVENTIVE MAINTENANCE WAS PERFORMED. THE CUSTOMER RAN "A FEW" PATIENT SAMPLES AND ALL PATIENT SAMPLES SHOWED RESULTS OF (B)(6) WHICH IS "VERY RARE." THE CUSTOMER CHANGED TO A DIFFERENT REAGENT PACK AND REPEATED THE PATIENT SAMPLES. UPON REPEATING THE PATIENT SAMPLES, THE RESULT FOR 1 PATIENT SAMPLE WAS DISCREPANT. THE INITIAL RESULT WAS (B)(6). THE REPEAT RESULT WAS (B)(6). THE POSITIVE RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387410 ↗