The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0012-2015·Announced 2014-10-15

Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The affected lots could have NBF concentrations that are lower or higher than the desired specifications."

Plain-English summary

Richard-Allan Scientific Company is recalling 175 cases of Protocol 10% NBF, a tissue fixative used to store and fixate tissue prior to grossing and histological examination. The product is identified by Product Code 426-796 and Lot Number 298987.

The recall was initiated because the affected lots could have NBF concentrations that are lower or higher than the desired specifications. This deviation from specifications may affect the product's ability to properly prevent autolysis (degradation) of tissue.

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
Protocol 10% NBF 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.
Manufacturer
Richard-Allan Scientific Company
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
175

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: 426-796 Lot Number: 298987

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 →

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