FDA Medical Device Recalls (openFDA)
BioMerieux SA: Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
- Recall number
- Z-1947-2015
- Recalling firm
- BioMerieux SA
- Product
- Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2015-06-12
- Posted
- 2015-07-01
- Terminated
- 2017-08-01
- Reason
- QC results were out of range resulting in false resistant strains.
- 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
- 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.
- Lot, serial or model codes
- 1002774320, 1002377890, 1002590470, 1002775330, 1002379610
- 510(k) numbers
- ["K981137"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28