The Recall Desk
ModerateFDA (Devices)·Z-2165-2017·Announced 2017-06-07

Pointe Scientific Lactate Dehydrogenase Reagent Set Recalled for Stability Issues

Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase Reagent Sets because the product's stability claim is not being met.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a stability claim not being met, which is a quality issue without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Medtest Holdings, Inc. is recalling the Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set, Model Number L7572. This product is used for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. The recall involves 716.146L of the reagent set in all configurations.

The recall was initiated because the product's stability claim is not being met. This means the reagent may not perform as expected over its intended shelf life, potentially affecting the accuracy of laboratory test results.

The product was distributed nationwide. Users of this reagent set should stop using it and contact Medtest Holdings, Inc. for further instructions or a replacement.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • L7572 all configurations

Distribution

Distributed nationwide across the United States.