Medtest Holdings, Inc. recalls Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap.…

Recall date

February 15, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2116-2017

FDA classification

Class III

Brand / firm

Medtest Holdings, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.