VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.

Class I - Dangerous
🏥 Medical Devices Recalled: April 20, 2017 Biomerieux Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    7930118203 24/Mar/18
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biomerieux Inc
Reason for Recall:
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.

Product Codes/Lot Numbers:

7930118203 24/Mar/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2516-2017

Related Recalls

Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

Jun 26, 2025 Diagnostic Equipment View Details →

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.

Mar 14, 2024 Diagnostic Equipment View Details →

For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.

Feb 6, 2023 Surgical Instruments Nationwide View Details →