Recall Z-2116-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2116-2017
Creator: U.S. Food and Drug Administration
Published: 2012-02-15

Class III · Terminated

Class III FDA medical device recall by Medtest Holdings, Inc., initiated 2012-02-15, terminated 2017-06-02. It names one FDA 510(k) clearance: K941132. 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.. Reason: 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..

Recalling firm: Medtest Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-02-15
Terminated: 2017-06-02
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K941132 — LIQUID AST (SGOT)REAGENT SETPointe Scientific, Inc.,·cleared 1994-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.