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

FDA device recall Z-1947-2015 · posted 2015-07-01 · Terminated

Recall details

Recalling firm

BioMerieux SA

Reason for recall

QC results were out of range resulting in false resistant strains.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

JWY

Quantity affected

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: Aust

Date initiated

2015-06-12

Date posted

2015-07-01

Date terminated

2017-08-01

Location

Marcy L'Etoile, France

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