—#48238

Product

bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K021123
Affected lot / code info: Lot number 1013177 (Product No. 259790)

Why it was recalled

Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.

Root cause (FDA determination)

Other

Action the firm took

Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.

Timeline

Recall initiated: 2006-08-17
Posted by FDA: 2006-12-05
Terminated: 2009-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48238. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.