The Recall Desk
LowFDA (Devices)·Z-0013-2015·Announced 2014-10-15

Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

Richard-Allan Scientific is recalling 285 cases of its Specimen Transportation System because the NBF concentrations may not meet specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The issue is a deviation from concentration specifications without reported injuries.

Plain-English summary

Richard-Allan Scientific Company is recalling 285 cases of its Specimen Transportation System. The product contains 10% Neutral Buffered Formalin (NBF), which is used to store and fixate tissue prior to grossing and histological examination to prevent autolysis.

The recall is being issued because the affected lots could have NBF concentrations that are lower or higher than the desired specifications. The specific product code is 534801 and the lot number is 296986.

The product was distributed nationwide in the United States and in Canada. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product.

The recalled product

Product
Richard-Allan Scientific Specimen Transportation System. 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
285

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: 534801 Lot Number: 296986

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 →