cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701...
FDA Recall #Z-0489-2025 — Class II — October 17, 2024
Product Description
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
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)
Recalling Firm
Roche Diagnostics Operations, Inc. — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
458 units
Distribution
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Code Information
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated