—#210764

Product

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

FDA product code: LPS — Urinary Homocystine (Nonquantitative) Test System
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K113793
Affected lot / code info: UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024

Why it was recalled

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,

Timeline

Recall initiated: 2024-10-17
Posted by FDA: 2024-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.