Cobas HCYS Test (Roche) – Calibration Signal Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Products Sold
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Roche Diagnostics Operations, Inc. is recalling cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/70 due to Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IN, IA, NJ, NY, OK, SC, TX
Page updated: Jan 10, 2026