The Recall Desk
ModerateFDA (Devices)·Z-0016-2015·Announced 2014-10-15

Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.

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 I, which typically indicates a low risk of adverse health consequences, and the source text does not report any injuries or illnesses.

Plain-English summary

Richard-Allan Scientific Company is recalling 199 cases of 10% Neutral Buffered Formalin (Product Code 51401, Lot Number 300649). This product is used to store and fixate tissue prior to grossing and histological examination, serving as a primary fixative to prevent tissue degradation.

The recall was initiated because the affected lots could have concentrations that are lower or higher than the desired specifications. The product was distributed nationwide in the United States and in Canada.

Users of this product should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Affected units
199

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)

  • Product Code: 51401 Lot Number: 300649

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Richard-Allan Scientific Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →