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

FDA device recall Z-1067-2010 · posted 2010-03-11 · Terminated

Recall details

Recalling firm

DRG International Inc

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.

Action taken

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

Status

Terminated

Product code

JSO

Quantity affected

325 (5 x 5000ml), 65 5 L packs

Distribution

Nationwide distribution

Date initiated

2009-11-09

Date posted

2010-03-11

Date terminated

2012-05-14

Location

Mountainside, NJ