Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
FDA device recall Z-0165-2009 · posted 2008-10-22 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
- Action taken
- The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Distribution
- Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
- Date initiated
- 2008-06-24
- Date posted
- 2008-10-22
- Date terminated
- 2009-10-22
- 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 |
|---|---|---|
| ELECSYS 2010 ANALYZER (K961481) | Boehringer Mannheim Corp. | 1996-06-14 |