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Terminated

BacT/ALERT(BTA) Classic instruments.

FDA Recall Z-0456-05 · Posted 2005-02-01

Recalling FirmbioMerieux
Recall StatusTerminated
Product CodeMDB
Date Initiated2004-09-17
Date Terminated2009-12-08
Product Quantity1626 units

Reason for Recall

Over heating of memory board.

Firm Action

Consignees were notified by letter on September 17, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, 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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