Z-1947-2015Class II

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic

Name: Z-1947-2015 Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic
Creator: BioMerieux SA
Published: 2015-06-12
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-06-12 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic on 2015-06-12. FDA classified it as Class II and gives the reason as "QC results were out of range resulting in false resistant strains". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1947-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2015-07-01
Terminated: 2017-08-01
Recalling firm: bioMerieux, Inc.
Product: Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: QC results were out of range resulting in false resistant strains.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required actions: Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256 lots reported in table 1. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement. bioMrieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.
Quantity in commerce: 674
Distribution: Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
Product codes and lots: 1002774320, 1002377890, 1002590470, 1002775330, 1002379610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1947-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-01

Product code JWY

K981137Class IIEtest CefotaximeAb Biodisk / cleared 1998-06-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)