Roche LIPC Lipase Colorimetric Reagent recallZ-0688-2008 · Roche Diagnostics Corp. · initiated Dec 3, 2007
Terminated All recalls posted in February 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0688-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 3, 2007
- Posted by the FDA
- Feb 8, 2008
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 9,817 kits.
- Product code
- JFJ
- FDA submissions
- K972250
- Distribution
- Nationwide Distribution
Product description
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
Code information (models, lots, serial 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.
Other devices under the same FDA submission
7 devices cleared under K972250 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- UreaBUN 5171873190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN8 reports
- UreaBUN 4460715190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN6 reports
- Amylase EPS ver2 3183742122Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE4 reports
- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122Roche Diagnostics GmbH · KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE3 reports
- alpha-Amylase EPS ver.2 5167027190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 report
- a-Amylase EPS ver.2 08056811190Roche Diagnostics GmbH · CATALYTIC METHODS, AMYLASE1 report
- Urea/Bun 08058806190Roche Diagnostics GmbH · UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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