Creatine Kinase recallZ-3187-2024 · Roche Diagnostics Operations, Inc. · initiated Aug 15, 2024
Open, Classified
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 Operations, Inc. 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
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
FDA root cause category: Under Investigation by firm
What the company is doing
Roche issued Urgent Medical Device Corrections,TP-02225 and TP-02227 via UPS ground (08/15/2024). Roche engaged Sedgwick a third party recall company. Letter states reason for recall, health risk and action to take: Creatine Kinase kits, lot number 755471 expired on 06/30/2024. Ensure any inventory you have of this lot has been discarded per your local guidelines. " Follow your laboratory s standard operating procedures to determine specific clinical implications for your patients and whether retrospective review of patient results is required. " Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " If you received Recall Response Form (TP-02226) with this UMDC, complete all sections and fax it to 1-800-898-6169 or email it to [email protected] by September 1, 2024. If you did not receive the Recall Response Form with this UMDC, disregard this action. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information in this UMDC.
Recall details
- Recall number
- Z-3187-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 15, 2024
- Posted by the FDA
- Sep 20, 2024
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 6504 units
- Product code
- JHS
- FDA submissions
- K160570
- Distribution
- US Nationwide distribution.
Product description
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
Code information (models, lots, serial numbers)
UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Creatine Kinase 7190794190Roche Diagnostics GmbH · DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES1 recall11 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K160570 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Creatine Kinase 08057460190Roche Diagnostics GmbH · DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES1 report
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 16, 2026. Text above is shown as published by the FDA.
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