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Terminated

BacT/ALERT FN Culture Bottles, Product Number 259793

FDA Recall Z-1189-2007 · Posted 2007-08-22

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMBD
Date Initiated2007-02-16
Date Terminated2009-12-08
Product Quantity2,403 cases (100 bottles per case)

Reason for Recall

Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

Firm Action

Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.

Root Cause

Other

Distribution Pattern

Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992432BACT/ALERT FNOrganon Teknika Corp. · 1999-09-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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