Roche ISE Internal Standard Gen.2 for use on Roche cobas c… recallZ-0542-2009 · Roche Diagnostics Corp. · initiated Sep 15, 2008
Terminated All recalls posted in January 2009
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
Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
FDA root cause category: Package design/selection
What the company is doing
Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
Recall details
- Recall number
- Z-0542-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 15, 2008
- Posted by the FDA
- Jan 6, 2009
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 7909
- Product code
- JIX
- FDA submissions
- K060373
- Distribution
- Nationwide Distribution.
Product description
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
Code information (models, lots, serial numbers)
Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601.
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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