VITEK® 2 AST-GP68Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026530792), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Product Quality Problem; Product Quality Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING TERMINATED RESULTS AND OBSERVING TAPE WRINKLES ON MULTIPLE CARDS IN ASSOCIATION WITH THE VITEK® 2 AST-GP68 TEST KIT (REF 22231, LOT 1331246403). THE CUSTOMER ALSO STATED THAT THE CARDS GAVE TERMINATED (TRM) RESULTS AND RESULTS WERE DELAYED > 24 HOURS. THE CUSTOMER THEN OPENED ADDITIONAL POUCHES TO EXAMINE CARDS AND FOUND AT LEAST 10 CARDS WITH A FILM DEFECT. THE NUMBER OF PATIENT SAMPLES FOR WHICH DELAYS OCCURRED DUE TO THE TAPE DEFECT AND TRM RESULTS WAS NOT DISCLOSED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DELAY LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11101856 ↗