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.

Roche Diagnostics Operations, Inc. 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 | SafeCheck