Date Initiated by Firm |
October 23, 2007 |
Date Posted |
May 14, 2008 |
Recall Status1 |
Terminated 3 on July 16, 2008 |
Recall Number |
Z-1624-2008 |
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 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215 |
Code Information |
Lot 518113 |
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 |
500/1-ml packs |
Distribution |
Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K. |
Total Product Life Cycle |
TPLC Device Report
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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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