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Terminated

BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA

FDA Recall Z-0644-2007 · Posted 2007-03-22

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMDB
Date Initiated2006-12-19
Date Terminated2009-12-08
Product Quantity1233 disks

Reason for Recall

Bottle data is not sent to BacT/ALERT 3D instrument.

Firm Action

A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEMOrganon Teknika Corp. · 1998-07-24K954468MB/BACT MYCROBACTERIA DETECTION SYSTEMOrganon Teknika Corp. · 1996-07-22K934593BACT/ALERT 120Organon Teknika Corp. · 1994-02-09K903505BACT/ALERT (TM)Organon Teknika Corp. · 1991-03-12

Official Source

View FDA Recall →

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

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