Recall Z-0576-2008 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Roche Diagnostics Corp.
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
| Date | Mar 4, 2008 (initiated Dec 4, 2007) |
| Status | Terminated |
| Reason | Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 1 |
| Distribution | USA Distribution in the state of Nebraska. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060373 | COBAS 6000 SERIES SYSTEM Roche Diagnostics, Mar 13, 2006 |