Food, drugs, devices › BioMerieux SA
Device recall: API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniat
FDA enforcement event 73060 is a device recall by BioMerieux SA of Marcy L'Etoile, N/A, initiated 8 Jan 2016 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 14 Jul 2017. Initiation: voluntary: firm initiated. BioMerieux SA has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
BioMerieux SA, Marcy L'Etoile, N/A, France.
Reason for recall
"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."
Distribution
"Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0756-2016 | 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. | 13,271 | Class II | Terminated | 10 Feb 2016 |
Context
Other enforcement events for BioMerieux SA
All 21 events for BioMerieux SA
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.