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Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the...

FDA Recall #Z-2165-2017 — Class II — July 8, 2011

Recall #Z-2165-2017 Date: July 8, 2011 Classification: Class II Status: Terminated

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.

Recalling Firm

Medtest Holdings, Inc. — Canton, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

716.146L total

Distribution

Nationwide

Code Information

L7572 all configurations

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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