Class 2 Device Recall cobas HCYS, Homocysteine Enzymatic Assay

• Date Initiated by Firm: October 17, 2024
• Date Posted: November 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0489-2025
• Recall Event ID: 95609
• 510(K)Number: K113793
• Product Classification: Urinary homocystine (nonquantitative) test system - Product Code LPS
• Product: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
• Code Information: UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 317-521-4343
• Manufacturer 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)
• FDA Determined 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 in Commerce: 458 units
• Distribution: US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPS