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Terminated

Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany

FDA Recall Z-0499-2007 · Posted 2007-02-17

Recalling FirmEMD Chemicals Inc
Recall StatusTerminated
Product CodeJ
Date Initiated2006-08-17
Date Terminated2008-06-06
Product Quantity800 packages of 50 strips each.

Reason for Recall

Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present

Firm Action

A Recall Letter was issued by EMD Chemicals on 8/17/2006 to discontinue product usage and for product return.

Root Cause

Other

Distribution Pattern

Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.

Official Source

View FDA Recall →

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

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