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U.S. Department of Health and Human Services

Class 3 Device Recall Remel RapID Inoculation Fluid 2ML

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  Class 3 Device Recall Remel RapID Inoculation Fluid 2ML see related information
Date Initiated by Firm October 23, 2007
Date Posted May 14, 2008
Recall Status1 Terminated 3 on July 16, 2008
Recall Number Z-1625-2008
Recall Event ID 46801
Product Classification Microorganism differentiation and identification device - Product Code LIB
Product Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215
Code Information Lot 521354
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215
For Additional Information Contact Robert E. Booth
913-895-4007
Manufacturer Reason
for Recall		 Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
FDA Determined
Cause 2		 Other
Action Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.
Quantity in Commerce 554/2-ml packs
Distribution Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.
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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