Home / Recalls / Medtest Holdings, Inc. / Z-2116-2017

Z-2116-2017 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
February 15, 2012
Termination Date
June 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
119.168L across All lots

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution

Code Information

Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.

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