Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Le

FDA device recall Z-0578-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JSK

Quantity affected

1/10/100 ml/vials/packs

Distribution

Nationwide Distribution to FL

Date initiated

2014-11-13

Date posted

2014-12-12

Date terminated

2015-01-29

Location

Lenexa, KS

Related 510(k) clearances