cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Recall
- Recall Number
- Z-0489-2025
- Event Number
- 95609
- Firm
- Roche Diagnostics Operations, Inc.
- FEI Number
- 1823260
- Product Code
- LPS
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 17, 2024
- Posted
- November 19, 2024
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
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
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
458 units