Reported Feb 5, 2014 · Terminated

API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses…

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?

  • API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
Lot codes and dates
  • Lot numbers
    • 1002210010
    • 1002210011
    • 1002287930
    • 1002287931
    • 1002350760
    • 1002390940
    • 1002390941
    • 1002518070
    • 1002518071
    • 1002518072
    • 1001915090
    • 1001915091
    • 1001915092
    • 1001932340
    • 1001998120 and 1002129350
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, 4:51 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.