Class II

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

Roche Diagnostics Operations, Inc. · October 17, 2024

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,

States Affected

FL, IA, IN, NJ, NY, OK, SC, TX

Quantity Affected

458 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0489-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.