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U.S. Department of Health and Human Services

Class 2 Device Recall Roche LIPC Lipase colorimetric reagent

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 Class 2 Device Recall Roche LIPC Lipase colorimetric reagentsee related information
Date Initiated by FirmDecember 03, 2007
Date PostedFebruary 08, 2008
Recall Status1 Terminated 3 on June 11, 2008
Recall NumberZ-0688-2008
Recall Event ID 45910
510(K)NumberK972250 
Product Classification Porphyrins fluorometric measurement - Product Code JFJ
ProductRoche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
Code Information Lots 68580101, exp. 11/30/2007; 68711401, exp. 1/31/2008; 68873201, exp. 3/31/2008; 69119401, exp. 5/31/2008 and 69279301, exp. 7/31/2008.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.
FDA Determined
Cause 2		Process design
ActionConsignees were sent and Urgent Medical Device Correction notice dated 12/03/07. The notice provided instructions for conducting an additional wash cycle whenever both the LDL-Cholesterol assays and Lipases assay are used on the COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers. Contact Roche Technical Support at 1-800-428-2336 for questions regarding these instructions.
Quantity in Commerce9,817 kits.
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JFJ
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