Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis,
FDA device recall Z-0576-2008 · posted 2008-03-04 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
- Action taken
- Roche Diagnostics contacted the consignee by phone on 12/4/07 and by follow-up letter dated 12/4/07. The user was instructed to discontinue use of two CRP assays on this analyzer. The letter described a workaround and that a new revision of software, due out first quarter 2008, will fix this.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 1
- Distribution
- USA Distribution in the state of Nebraska.
- Date initiated
- 2007-12-04
- Date posted
- 2008-03-04
- Date terminated
- 2008-08-04
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS 6000 SERIES SYSTEM (K060373) | Roche Diagnostics | 2006-03-13 |