cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Recall Initiated
- October 17, 2024
- Posted
- November 19, 2024
- Recall Number
- Z-0489-2025
- Quantity
- 458 units
- Firm Location
- Indianapolis, IN
Reason for Recall
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Distribution
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Lot / Code Info
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Root Cause
Under Investigation by firm
Action Taken
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