Recall Z-1947-2015 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
| Date | Jul 1, 2015 (initiated Jun 12, 2015) |
| Status | Terminated |
| 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 |
| 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, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981137 | ETEST CEFOTAXIME Ab Biodisk, Jun 9, 1998 |