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U.S. Department of Health and Human Services

Class 2 Device Recall N acetylprocainamide reagent

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  Class 2 Device Recall N acetylprocainamide reagent see related information
Date Initiated by Firm February 05, 2010
Date Posted September 08, 2010
Recall Status1 Terminated 3 on November 01, 2010
Recall Number Z-2386-2010
Recall Event ID 54624
510(K)Number K060738  
Product Classification Analyzer, enzyme, for clinical use - Product Code LAN
Product ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.
Code Information 14456200
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256
For Additional Information Contact Doyia Turner
317-576-2000 Ext. 249
Manufacturer Reason
for Recall
The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.
FDA Determined
Cause 2
Error in labeling
Action Roche issued an "Urgent Medical Device Removal" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.
Quantity in Commerce 40 kits
Distribution Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.
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.
510(K) Database 510(K)s with Product Code = LAN and Original Applicant = ROCHE DIAGNOSTICS CORP.
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