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Terminated

MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691

FDA Recall Z-0668-05 · Posted 2005-04-06

Recalling FirmDade Behring
Recall StatusTerminated
Product CodeLON
Date Initiated2005-02-07
Date Terminated2005-07-05
Product Quantity324 boxes

Reason for Recall

There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

Firm Action

The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.

Root Cause

Other

Distribution Pattern

71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.

Official Source

View FDA Recall →

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

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