Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FB Reagent (REF 70562). FB reagent is an additional test Recalled by BioMerieux SA Due to bioMerieux identified a visual defect and activity issue...

Date: March 6, 2014
Company: BioMerieux SA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.

Affected Products

FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

Quantity: 33,853

Why Was This Recalled?

bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BioMerieux SA

BioMerieux SA has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report