—#49411

Product

BacT/ALERT 3D System Software, Blood Culturing System

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K934593
Affected lot / code info: All Models

Why it was recalled

Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Timeline

Recall initiated: 2006-08-14
Posted by FDA: 2007-05-03
Terminated: 2009-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49411. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.