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
Roche Diagnostics Operations, Inc.
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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