The Recall Desk
ModerateFDA (Devices)·Z-0842-2014·Announced 2014-02-05

Biomerieux Recalls API Listeria Kits Due to ZYM B Reagent Defect

Biomerieux is recalling API Listeria kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a diagnostic error (false negatives) rather than direct physical injury or a high-risk pathogen exposure, fitting the criteria for moderate severity.

Plain-English summary

Biomerieux is recalling 39,439 API Listeria kits (REF 10300) and associated ZYM B reagents (REF 70493). The recall is due to a visual defect and activity issue in the ZYM B reagent, which is used as an additional reagent for revealing the result of the DIM miniaturized biochemical test included in the API Listeria strips.

The defect may lead to false negative results in some API biochemical tests. The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations.

Users of these products should stop using the affected kits and reagents and contact Biomerieux for further instructions.

The recalled product

Product
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 mi
Manufacturer
Biomerieux France Chemin De L'Or
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
39,439

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Lot numbers: 1002210010
  • 1002210011
  • 1002287930
  • 1002287931
  • 1002350760
  • 1002390940
  • 1002390941
  • 1002518070
  • 1002518071
  • 1002518072
  • 1001915090
  • 1001915091
  • 1001915092
  • 1001932340
  • 1001998120 and 1002129350.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Biomerieux France Chemin De L'Or under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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