VITEK® 2 AST-GN99Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026608149), received between Sep 30, 2020 and Sep 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K072038, K091899, K103752, K110106, K113200, K152075, K161217, K161227, N50510); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Mar 14, 2024Open, Classified

   Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

   Z-1464-2024 · Root cause: Employee error · Recall details · FDA record ↗

2. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0854-2023 · Root cause: Storage · Recall details · FDA record ↗

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 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING INCORRECT ESBL PHENOTYPE PROPOSALS FOR TWO PATIENT ESCHERICHIA COLI ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GN99 TEST KIT (REF 423102, LOT 6891406203). THE CUSTOMER PROVIDED LAB REPORTS RELATED TO TWO DIFFERENT PATIENT ISOLATES WHERE ESBL PHENOTYPE WAS PROPOSED FOR INITIAL TESTING AND FLAGGED FOR REVIEW, BUT NOT PROPOSED FOR REPEAT TESTING. THE CUSTOMER PERFORMS REPEAT TESTING USING THE PURITY PLATE IF AN ESBL PHENOTYPE IS PROPOSED BY ADVANCED EXPERT SYSTEM¿ (AES). HOWEVER, THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE TEST METHODS TO CONFIRM ESBL PHENOTYPES. GLOBAL CUSTOMER SERVICE (GCS) PERFORMED THE 8.01 AES DEMONSTRATOR FOR THE INITIAL AND REPEAT TESTS FOR BOTH PATIENTS WITH THE FOLLOWING RESULTS: FOR THE INITIAL RUN FOR BOTH PATIENT A AND B, THE AES DEMO PROPOSED THE SAME FIVE (5) PHENOTYPES THAT WERE ALSO PROPOSED ON THE CUSTOMER'S REPORT: ACQUIRED PASE + CASE (AMPC), ACQUIRED PENICILLINASE, CEPHALOSPORINASE (AMPC), EXTENDED SPECTRUM BETA LACTAMASE, AND SHV1HYPERPRODUCTION. ALL PHENOTYPES WERE EQUALLY PROPOSED WITH TWO STARS AS THERE WAS NOT A PERFECT MATCH FOR ANY OF THE PHENOTYPES. HERE AES IS PROPOSING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10606626 ↗
• MalfunctionSep 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING INCORRECT ESBL PHENOTYPE PROPOSALS FOR TWO PATIENT ESCHERICHIA COLI ISOLATES IN ASSOCIATION WITH THE VITEK® 2 AST-GN99 TEST KIT (REF (B)(4), LOT 6891406203). THE CUSTOMER PROVIDED LAB REPORTS RELATED TO TWO DIFFERENT PATIENT ISOLATES WHERE ESBL PHENOTYPE WAS PROPOSED FOR INITIAL TESTING AND FLAGGED FOR REVIEW, BUT NOT PROPOSED FOR REPEAT TESTING. THE CUSTOMER PERFORMS REPEAT TESTING USING THE PURITY PLATE IF AN ESBL PHENOTYPE IS PROPOSED BY ADVANCED EXPERT SYSTEM¿ (AES). HOWEVER, THE CUSTOMER DOES NOT PERFORM ANY ALTERNATIVE TEST METHODS TO CONFIRM ESBL PHENOTYPES. GLOBAL CUSTOMER SERVICE (GCS) PERFORMED THE 8.01 AES DEMONSTRATOR FOR THE INITIAL AND REPEAT TESTS FOR BOTH PATIENTS WITH THE FOLLOWING RESULTS: FOR THE INITIAL RUN FOR BOTH PATIENT A AND B, THE AES DEMO PROPOSED THE SAME FIVE (5) PHENOTYPES THAT WERE ALSO PROPOSED ON THE CUSTOMER'S REPORT: ACQUIRED PASE + CASE (AMPC), ACQUIRED PENICILLINASE, CEPHALOSPORINASE (AMPC), EXTENDED SPECTRUM BETA LACTAMASE, AND SHV1HYPERPRODUCTION. ALL PHENOTYPES WERE EQUALLY PROPOSED WITH TWO STARS AS THERE WAS NOT A PERFECT MATCH FOR ANY OF THE PHENOTYPES. HERE AES IS PROPOSING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10606585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072038, K091899, K103752, K110106, K113200, K152075, K161217, K161227, N50510. One submission often covers many models, so check the product and lot details in each record.

• Z-0861-2023 · Nov 9, 2022 · Open, Classified
  VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829