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Terminated

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

FDA Recall Z-0643-2007 · Posted 2007-03-22

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMDB
Date Initiated2007-01-11
Date Terminated2009-12-08
Product Quantity2136 cases (100 bottles per case)

Reason for Recall

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

Firm Action

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

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020813BACT/ALERT FA CULTURE BOTTLEbioMerieux, Inc. · 2002-04-17

Official Source

View FDA Recall →

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

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