The Recall Desk
ModerateFDA (Devices)·Z-0843-2014·Announced 2014-02-05

BioMérieux Recalls API NH Kits Due to ZYM B Reagent Defect

BioMérieux is recalling API NH 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, but the hazard is a diagnostic error (false negatives) rather than a direct physical injury or contamination, fitting the Moderate category for low-risk issues without reported harm.

Plain-English summary

BioMérieux is recalling 39,439 API NH (REF 10400) kits, which include ZYM B reagents and API Listeria kits. The recall is due to a visual defect and activity issue identified in the ZYM B reagent (REF 70493). This defect can 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. The recall covers specific lot numbers, including 1001896203, 1001957530, and 1001957531, among others.

Users of these kits should stop using the affected ZYM B reagents and API NH kits immediately. Laboratories should verify their lot numbers against the recall list and contact BioMérieux for further instructions on returning or replacing the products.

The recalled product

Product
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyp
Manufacturer
Biomerieux France Chemin De L'Or
Category
Medical Device — In Vitro Diagnostics
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 (20)

  • Lot numbers: 1001896203
  • 1001957530
  • 1001957531
  • 1002112170
  • 1002112171
  • 1002112172
  • 1002279351
  • 1002340500
  • 1002112173
  • 1002171111
  • 1002171110
  • 1002279350
  • 1002279352
  • 1002340501
  • 1002340502
  • 1002340503
  • 1002412550
  • 1002412551
  • 1002485910
  • 1002485911

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 →

Related recalls

Same manufacturer · Biomerieux France Chemin De L'Or

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Same hazard · false negative result

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