The Recall Desk
ModerateFDA (Devices)·Z-1477-2014·Announced 2014-04-30

BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results

BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue can cause false negative results in Rapid ID 32 strips and 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 hazard is a diagnostic error (false negatives) rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

BioMerieux SA is recalling ZYM B reagent (REF 70493) and FB reagent (REF 70562) due to a visual defect and activity issue. The company identified that these defects lead to false negative results in some Rapid ID 32 strips and API biochemical tests that utilize these specific reagents.

The affected products are used in standardized systems for the group or species identification of microorganisms. The recall includes 33,853 units distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international countries. Specific lot codes and expiration dates are listed in the agency record.

Users of these reagents should stop using the affected lots immediately and contact BioMerieux for instructions on return or replacement. This recall is a precautionary measure to prevent inaccurate diagnostic results.

The recalled product

Product
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
33,853

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 (13)

  • Code - 1002786740
  • Exp. Date 6/3/2014
  • 1002809140
  • Exp. Date 6/18/2014
  • 1002814890
  • Exp. Date 9/9/2014
  • 1002814891
  • 1002826750
  • 1002869720
  • 1002869721
  • Exp. Date 12/13/2014
  • 1002485910
  • 1002485911

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 4 recalled by BioMerieux SA 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 4 products in this recall →

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