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VITEK 2 AST-N351 Test Kit

FDA Recall #Z-0847-2019 — Class II — December 13, 2018

Recall #Z-0847-2019 Date: December 13, 2018 Classification: Class II Status: Terminated

Product Description

VITEK 2 AST-N351 Test Kit

Reason for Recall

False Positive ESBL Phenotype

Recalling Firm

bioMerieux, Inc. — Durham, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

30,292 cartons (20 cards per carton)

Distribution

UK and Ireland

Code Information

Ref: 421257 ALL LOTS

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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