—#118595

Product

Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K070262
Affected lot / code info: Lot 1227786, Exp. 31AUG2013

Why it was recalled

Cartridges may contain individual discs which were not impregnated with antibiotic.

Root cause (FDA determination)

Process design

Action the firm took

ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questions regarding this recall call 913-895-4185.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Nationwide Distribution: US including Puerto Rico.

Timeline

Recall initiated: 2013-04-09
Posted by FDA: 2014-01-21
Terminated: 2014-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.