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U.S. Department of Health and Human Services

Class 2 Device Recall Remel MacConkey Agar w/Sorbitol

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  Class 2 Device Recall Remel MacConkey Agar w/Sorbitol see related information
Date Initiated by Firm February 21, 2007
Date Posted March 14, 2007
Recall Status1 Terminated 3 on March 06, 2008
Recall Number Z-0621-2007
Recall Event ID 37423
Product Classification Agar - Product Code JSI
Product Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
Code Information Lot 506069, Exp. 2007/03/20
Recalling Firm/
Manufacturer		 Remel, Inc.
12076 Santa Fe Trail Dr
Lenexa KS 66215
For Additional Information Contact Earleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		 False negative results for sorbitol fermenting bacteria such as E. Coli 0157.
FDA Determined
Cause 2		 Other
Action Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.
Quantity in Commerce 694/10-pack boxes
Distribution Nationwide.
Total Product Life Cycle TPLC 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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