—#66461

Product

Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250

FDA product code: JFJ — Catalytic Methods, Amylase
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K972250
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-12-03
Posted by FDA: 2008-02-08
Terminated: 2008-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.