—#117180

Product

Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K860153
Affected lot / code info: Lots 1194944 and 1198342

Why it was recalled

Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).

Recalling firm

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

Distribution

Distribution pattern: US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.

Timeline

Recall initiated: 2013-03-25
Posted by FDA: 2013-08-26
Terminated: 2014-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117180. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.