FDA-Device2017-05-24Class III
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Medtest Holdings, Inc.
Hazard
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
Sold states
US Nationwide Distribution
Affected count
119.168L across All lots
Manufactured in
5449 Research Dr, Canton, MI, United States
Products
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2116-2017Don't want to check this manually?
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