Z-0756-2016Class II

API ZYM Bx2 (Ref 70493)

Name: Z-0756-2016 API ZYM Bx2 (Ref 70493)
Creator: BioMerieux SA
Published: 2016-01-08
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-01-08 / Terminated

FDA source

BioMerieux SA began a recall of 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... on 2016-01-08. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0756-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-02-04
Terminated: 2017-07-14
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
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.
FDA root cause: Other
Action: BioMrieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their files, and forward the information to all parties that may use the product. For additional assistance or have any questions, contact your local bioMrieux Customer Service representative.
Quantity in commerce: 13,271
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, WI, WY
Product codes and lots: Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0756-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0756-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-04

Product code LIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)