RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Class I - Dangerous

🏥 Medical Devices Recalled: November 9, 2021 Biomerieux Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
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:: There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Product Codes/Lot Numbers:

Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0422-2022

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