Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
FDA Recall Z-0576-2008 · Posted 2008-03-04
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJY
Date Initiated2007-12-04
Date Terminated2008-08-04
Product Quantity1
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
USA Distribution in the state of Nebraska.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.