Homocysteine Enzymatic Assay recallZ-0489-2025 · Roche Diagnostics Operations, Inc. · initiated Oct 17, 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
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
FDA root cause category: Under Investigation by firm
What the company is doing
Roche issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/17/2024 via UPS Ground. The notice explained the issue, clinical significance, and requested the following actions be taken: "" HCYS kits lot number 747029 expired on September 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." For questions: contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336
Recall details
- Recall number
- Z-0489-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 17, 2024
- Posted by the FDA
- Nov 19, 2024
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 458 units
- Product code
- LPS
- FDA submissions
- K113793
- Distribution
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Product description
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Code information (models, lots, serial numbers)
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Homocysteine Enzymatic Assay 6542921190Roche Diagnostics GmbH · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K113793 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Homocysteine Enzymatic Assay 08057826190Roche Diagnostics GmbH · URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM1 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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