Recall Z-0489-2025 ยท LPS Urinary Homocystine (Nonquantitative) Test System
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
| Date | Nov 19, 2024 (initiated Oct 17, 2024) |
| Status | Open, Classified |
| 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 faci |
| Quantity | 458 units |
| Distribution | US: NJ, TX, NY, FL, IN, TX, OK, SC, IA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113793 | HOMOCYSTEINE TEST Roche, Jun 5, 2012 |