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U.S. Department of Health and Human Services

Class 2 Device Recall chromID Salmonella Agar

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  Class 2 Device Recall chromID Salmonella Agar see related information
Date Initiated by Firm September 06, 2013
Date Posted October 28, 2013
Recall Status1 Terminated 3 on June 24, 2014
Recall Number Z-0087-2014
Recall Event ID 66290
Product chromID Salmonella Agar, Reference No. 43621.

A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
Code Information Lot 1002234210 and 1002300040
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Alan Bergold, PhD
919-620-2599
Manufacturer Reason
for Recall		 Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall letters were issued to the US customers by Biomeriux, Durham, NC on 9/6/2013.
Quantity in Commerce 90
Distribution Nationwide Distribution.
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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