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Terminated

Bac T/ALERT 3D Control Module

FDA Recall Z-0612-05 · Posted 2005-09-07

Recalling FirmBIOMERIEUX, INC.
Recall StatusTerminated
Product CodeMDB
Date Initiated2005-05-27
Date Terminated2006-09-21
Product Quantity744 units

Reason for Recall

A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

Firm Action

Consignees were notified by letter on May 27, 2005.

Root Cause

Other

Distribution Pattern

Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K903505BACT/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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