Roche Diagnostics Corp. Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Roche Diagnostics Corp. is recalling Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., India due to 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 uni. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026