—#125419

Product

Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.

FDA product code: JSK — Supplement, Culture Media
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K831469
Affected lot / code info: Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015

Why it was recalled

The product may contain high levels of microbial contamination

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Thermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you. 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 Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.

Timeline

Recall initiated: 2014-01-24
Posted by FDA: 2014-02-26
Terminated: 2014-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125419. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.