The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1478-2014·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 caused false negative results in Rapid ID 32 strips and API biochemical 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where the defect leads to false negative results, potentially affecting patient care, but no specific injuries or illnesses are reported in the source text.

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 led to false negative results in some Rapid ID 32 strips and API biochemical tests that utilize these specific reagents.

The affected products are included in API NH (REF 10400) and API Listeria (REF 10300) systems, which are standardized biochemical test kits used for the identification of microorganisms. The recall covers 33,853 units distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international countries.

Consumers and healthcare facilities should stop using the affected reagents and contact BioMerieux for further instructions or a replacement. The specific lot codes and expiration dates for the affected units are listed in the official recall documentation.

The recalled product

Product
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs 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 (10)

  • Code - 1002569040
  • Exp. Date 8/29/2014
  • 1002569041
  • Exp. Date 8/296/2014
  • 1002587190
  • Exp. Date 9/3/2014
  • 1002856790
  • Exp. Date 7/18/2014
  • 1002856800
  • Exp. Date 6/12/2014

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 →

Related recalls

Same manufacturer · BioMerieux SA

See all →

Same hazard · false negative result

See all →

Similar recalls