Recall Z-1068-2010 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
DRG International Inc
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.
| Date | Mar 11, 2010 (initiated Nov 9, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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 ret |
| Quantity | 2236 L (90 x 5000 ml), 443 5 L packs, 21 1 L packs. |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.