FDA-Device2024-11-27Class II
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Hazard
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Sold states
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Affected count
458 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0489-2025Don't want to check this manually?
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