ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Class I - Dangerous

🏥 Medical Devices Recalled: June 24, 2021 Biomerieux Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Product Codes/Lot Numbers:

Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2226-2021

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