Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
FDA device recall Z-0012-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
- Action taken
- Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 478
- Distribution
- United States
- Date initiated
- 2003-05-08
- Date posted
- 2003-10-15
- Date terminated
- 2003-12-09
- 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 |
|---|---|---|
| BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239) | Boehringer Mannheim Corp. | 1995-09-25 |