Roche COBAS 6000 Clinical Chemistry analyzer recallZ-0576-2008 · Roche Diagnostics Corp. · initiated Dec 4, 2007
Terminated All recalls posted in March 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0576-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 4, 2007
- Posted by the FDA
- Mar 4, 2008
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 1
- Product code
- JJY
- FDA submissions
- K060373
- Distribution
- USA Distribution in the state of Nebraska.
Product description
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250.
Code information (models, lots, serial numbers)
All cce and cc system configurations with core unit software version 02-03.
Other devices under the same FDA submission
11 devices cleared under K060373 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- cobas c 501 Module 4745914001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE1,628 reports
- cobas e 601 Immunoassay Analyzer 04745922001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE607 reports
- cobas c 311 4826876001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE203 reports
- Sodium electrode 10825468001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM99 reports
- Sodium electrode 10825468001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM26 reports
- Potassium Electrode 10825441001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM14 reports
- Chloride Electrode 3246353001Roche Diagnostics GmbH · ELECTRODE, ION-SPECIFIC, CHLORIDE13 reports
- Potassium electrode 10825441001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM12 reports
- cobas 6000 core unit 4745868001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE6 reports
- cobas 6000 c501 module 7790198001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE5 reports
- Chloride electrode 03246353001Roche Diagnostics GmbH · ELECTRODE, ION-SPECIFIC, CHLORIDE4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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