—#130810

Product

Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

FDA product code: JSK — Supplement, Culture Media
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K831469
Affected lot / code info: Lot Number: 1451506 Expiration: 26Feb2016

Why it was recalled

Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the states of ND, VT and TX.

Timeline

Recall initiated: 2014-10-17
Posted by FDA: 2014-11-10
Terminated: 2017-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.