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Terminated

Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928

FDA Recall Z-0498-2007 · Posted 2007-02-17

Recalling FirmEMD Chemicals Inc
Recall StatusTerminated
Product CodeJ
Date Initiated2006-08-17
Date Terminated2008-06-06
Product Quantity8 rolls

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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