Recall Z-2165-2017— Medtest Holdings, Inc.

Name: FDA recall Z-2165-2017
Creator: U.S. Food and Drug Administration
Published: 2011-07-08

Class II · Terminated

Class II FDA medical device recall by Medtest Holdings, Inc., initiated 2011-07-08, terminated 2017-06-02. It names one FDA 510(k) clearance: K973589. Product: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.. Reason: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met..

Recalling firm: Medtest Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-07-08
Terminated: 2017-06-02
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K973589 — LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,·cleared 1997-10-08

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 Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

Reason for recall

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.

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