Recalls / —

—#39928

Product

Bac T/ALERT 3D 60

FDA product code

MDB — System, Blood Culturing

Device class

Class 1

Medical specialty

Microbiology

510(k) numbers

K903505

Affected lot / code info

All Models (Not available in the US)

Why it was recalled

A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on May 27, 2005.

Recalling firm

Firm

BIOMERIEUX, INC.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK

Timeline

Recall initiated

2005-05-27

Posted by FDA

2005-09-07

Terminated

2006-09-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #39928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.