—#66617

Product

Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.

FDA product code: JJY — Multi-Analyte Controls, All Kinds (Assayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K060373
Affected lot / code info: All cce and cc system configurations with core unit software version 02-03.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: USA Distribution in the state of Nebraska.

Timeline

Recall initiated: 2007-12-04
Posted by FDA: 2008-03-04
Terminated: 2008-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66617. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.