Recalls / —

—#49956

Product

BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704

FDA product code

MDB — System, Blood Culturing

Device class

Class 1

Medical specialty

Microbiology

510(k) numbers

K020813

Affected lot / code info

Lot 1014768

Why it was recalled

Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on/about 01/12/2007.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.

Timeline

Recall initiated

2007-01-11

Posted by FDA

2007-03-22

Terminated

2009-12-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.