Reported Jan 11, 2023 · Ongoing

VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

    • VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS
    • CATALOG 415670
Lot codes and dates
  • UDI/DI 03573026437183
  • Batch Numbers2752252403
Amount recalled
218 units

This recall covers 94 products

The agency filed one notice per product. You are reading one of them; the other 93 are below.

81 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.