Z-0688-2008

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

Name: Z-0688-2008 Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis...
Creator: Roche Diagnostics Corp.
Published: 2007-12-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-12-03 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250 on 2007-12-03. The reason FDA records is "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+...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0688-2008
Status: Terminated
Initiated: 2007-12-03
Posted: 2008-02-08
Terminated: 2008-06-11
Recalling firm: Roche Diagnostics GmbH
Product: Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
Product code: JFJ Catalytic Methods, Amylase
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.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 9,817 kits.
Distribution: Nationwide Distribution
Product codes and lots: 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.

Product code JFJ

K972250Class IIRoche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. / cleared 1997-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)