VITEK2 GP-ID, REF 21342 IVD

Class I - Dangerous

🏥 Medical Devices Recalled: October 11, 2017 Biomerieux Infusion Pumps

What Should You Do?

Check if you have this product:
UDI 03573026131920, Lot Number 2420348103
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:: Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

VITEK2 GP-ID, REF 21342 IVD

Product Codes/Lot Numbers:

UDI 03573026131920, Lot Number 2420348103

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0074-2018

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