—#131512

Product

Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. 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: 1374439, Exp: 31 Aug 2015

Why it was recalled

Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to FL

Timeline

Recall initiated: 2014-11-13
Posted by FDA: 2014-12-12
Terminated: 2015-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131512. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.