Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250
FDA device recall Z-0688-2008 · posted 2008-02-08 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JFJ
- Quantity affected
- 9,817 kits.
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-12-03
- Date posted
- 2008-02-08
- Date terminated
- 2008-06-11
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K972250) | Roche Diagnostic Systems, Inc. | 1997-08-12 |