Class II — Potential Health Hazard

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

API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent Recalled by BioMerieux SA Due to Discrepant identification results related to API identification strips....

Date: January 8, 2016
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

API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.

Quantity: 13,271

Why Was This Recalled?

Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B 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