Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
Hazard
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.
What You Should Do
Remedy
Consignees 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.
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Products
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
- Brand
- Roche Diagnostics Corp.
- UPC
- 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.
Units Affected
9,817 kits.