—#133849

Product

Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.

FDA product code: JSK — Supplement, Culture Media
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K831469
Affected lot / code info: Lot No. 1545171

Why it was recalled

Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter. 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 to the states of : MI, ND, SC, TN, and TX.

Timeline

Recall initiated: 2015-02-05
Posted by FDA: 2015-03-02
Terminated: 2017-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.