Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0688-2008 · Posted 2008-02-08

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJFJ
Date Initiated2007-12-03
Date Terminated2008-06-11
Product Quantity9,817 kits.

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.

Firm Action

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.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972250ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTSRoche Diagnostic Systems, Inc. · 1997-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑