FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Recall number
- Z-0489-2025
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Status
- Open, Classified
- Initiated
- 2024-10-17
- Posted
- 2024-11-19
- Terminated
- not on file
- Reason
- Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 458 units
- Distribution
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
- Lot, serial or model codes
- UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
- 510(k) numbers
- ["K113793"]
- PMA numbers
- not on file
- Product code
- LPS
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28