FDA-Device2019-04-24Class II
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Roche Diagnostics Corporation
Hazard
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Sold states
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Affected count
774
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1194-2019Don't want to check this manually?
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