Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
This recall has been terminated (originally issued March 4, 2008).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- December 4, 2007
- Posted
- March 4, 2008
- Terminated
- August 4, 2008
- Recall Number
- Z-0576-2008
- Quantity
- 1
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
USA Distribution in the state of Nebraska.
Lot / Code Info
All cce and cc system configurations with core unit software version 02-03.
Root Cause
Software design
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.
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