FDA-Device2019-12-25Class II
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Roche Diagnostics Operations, Inc.
Hazard
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Sold states
US Nationwide distribution in the states of NJ, HI, IA.
Affected count
82 units (US)
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0679-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief