The Recall Desk
ModerateFDA (Devices)·Z-0841-2014·Announced 2014-02-05

BioMérieux Recalls ZYM B Reagent Due to Visual Defect and False Negatives

BioMérieux is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in API 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

BioMérieux is recalling ZYM B Reagent (REF 70493) due to a visual defect and activity issue. The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical tests included in API strips, which are used for the identification of microorganisms.

The defect and activity issue may lead to false negative results in some API biochemical tests that use the ZYM B reagent. The recall involves 39,439 kits, which include ZYM B reagents and API Listeria and API NH kits. The affected lot numbers are 1002171010, 1002295110, 1002360360, 1002421440, 1002485410, 1001951820, 1002011320, and 1002071020.

The product was distributed worldwide, including nationwide in the United States and to numerous international locations. Users of the affected products should stop using the ZYM B reagent and contact BioMérieux for further instructions.

The recalled product

Product
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 identifi
Manufacturer
Biomerieux France Chemin De L'Or
Category
Medical Device — Laboratory Reagent
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 (8)

  • Lot numbers: 1002171010
  • 1002295110
  • 1002360360
  • 1002421440
  • 1002485410
  • 1001951820
  • 1002011320
  • and 1002071020.

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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