Retiro De Equipo (Recall) de Device Recall Oxoid Legionella BCYE Growth Supplement

Recall

69771

Class 2

Z-0578-2015

2014-11-13

2014-12-12

Terminated

United States

2015-01-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131512

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

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.