Reported Feb 5, 2014 · Terminated

ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized…

Biomerieux France Chemin De L'Or

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 France Chemin De L'Or · Chemin De L'Orme · Marcy L'Etoile · N/A

Is this the product you have?

  • ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
Lot codes and dates
  • Lot numbers
    • 1002171010
    • 1002295110
    • 1002360360
    • 1002421440
    • 1002485410
    • 1001951820
    • 1002011320
    • and 1002071020
Amount recalled
39439 kits (includes ZYM B reagents, API Listeria * API NH kits)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.

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

Notice updated Nov 30, 2017 · Data as of Sep 19, 6:03 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.