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U.S. Department of Health and Human Services

Class 2 Device Recall CHROMagar

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 Class 2 Device Recall CHROMagarsee related information
Date Initiated by FirmNovember 09, 2009
Date PostedMarch 11, 2010
Recall Status1 Terminated 3 on May 14, 2012
Recall NumberZ-1067-2010
Recall Event ID 53841
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
ProductCHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro 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.
Code Information Catalog number VR952; All codes within expiry
FEI Number 2245285
Recalling Firm/
Manufacturer		 DRG International Inc
1167 US Highway 22
Mountainside NJ 07092-2807
For Additional Information ContactPaulina Maciejski
908-233-2079
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionTwo 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.
Quantity in Commerce325 (5 x 5000ml), 65 5 L packs
DistributionNationwide distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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