The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1475-2014·Announced 2014-04-30

BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue

BioMerieux SA is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in microbiological tests.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 a moderate severity recall involving a medical device.

Plain-English summary

BioMerieux SA is recalling 33,853 units of ZYM B Reagent (REF 70493) due to a visual defect and an activity issue. The ZYM B reagent is used to reveal the results of miniaturized biochemical tests included in API strips, which are used for the identification of microorganisms.

The activity issue identified by the manufacturer can lead to false negative results in some Rapid ID 32 strips and API biochemical tests that utilize the ZYM B reagent. This recall is classified as Class II by the FDA.

The affected product was distributed nationwide in the United States, including DC and Puerto Rico, as well as to numerous countries worldwide. Specific lot codes and expiration dates are listed in the recall documentation. Users should stop using the affected reagent and contact BioMerieux SA for further instructions.

The recalled product

Product
ZYM B Reagent (REF 70493). The 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…
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Reagent
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)

  • Codes - 1002706740
  • Exp. Date 10/14/2014
  • 1002717860
  • Exp. Date 10/24/2014
  • 1002742610
  • Exp. Date 10/30/2014
  • 1002760700
  • Exp. Date 11/4/2014
  • 1002821420
  • Exp. Date 11/26/2014
  • 1002857840
  • Exp. Date 12/12/2014
  • 1002860530

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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