—#114202

Product

Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K860153
Affected lot / code info: Lot 1186069

Why it was recalled

The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,

Timeline

Recall initiated: 2012-08-21
Posted by FDA: 2013-02-12
Terminated: 2013-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114202. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.