FDA recall Z-0489-2025

Product

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)

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-10-17

Report date

2024-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2025