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Terminated

CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

FDA Recall Z-1068-2010 · Posted 2010-03-11

Recalling FirmDRG International Inc
Recall StatusTerminated
Product CodeJSO
Date Initiated2009-11-09
Date Terminated2012-05-14
Product Quantity2236 L (90 x 5000 ml), 443 5 L packs, 21 1 L packs.

Reason for Recall

CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures.

Firm Action

Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important. If you have any questions, please contact customer service at (908) 233-0758.

Root Cause

Other

Distribution Pattern

Nationwide distribution

Official Source

View FDA Recall →

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

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