Z-1067-2010

CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A...

Name: Z-1067-2010 CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A...
Creator: DRG International Inc
Published: 2009-11-09
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2009-11-09 / Terminated / root cause: labeling and UDI

FDA source

DRG International Inc began a recall of CHROMagar 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... on 2009-11-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1067-2010
Status: Terminated
Initiated: 2009-11-09
Posted: 2010-03-11
Terminated: 2012-05-14
Recalling firm: DRG International, Inc.
Product: CHROMagar 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.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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.
Root cause tag: labeling and UDI
FDA 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 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 commerce: 325 (5 x 5000ml), 65 5 L packs
Distribution: Nationwide distribution
Product codes and lots: Catalog number VR952; All codes within expiry

Product code JSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)