Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 car

FDA device recall Z-0734-2014 · posted 2014-01-14 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

Action taken

Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

JTN

Quantity affected

45/5/50 - discs/cartridges/packs

Distribution

Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV

Date initiated

2013-11-21

Date posted

2014-01-14

Date terminated

2014-12-11

Location

Lenexa, KS

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