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Medtest Holdings, Inc. recalls Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic c
Recalled May 24, 2017 · FDA recall Z-2116-2017 · Medtest Holdings
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. · FDA Class III
Units
119.168L across All lots
Sold at
US Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Medtest Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →