The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0015-2015·Announced 2014-10-15

Richard-Allan Scientific Recalls Bio-Tite Specimen Containers Due to Concentration Issues

Richard-Allan Scientific is recalling Bio-Tite Specimen Containers because the NBF 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 383 cases of Bio-Tite Specimen Containers, Product Code 59601, Lot Number 300233. The product is used to store and fixate tissue prior to grossing and histological examination.

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 fixate tissue.

The product was distributed nationwide in the United States and in Canada. Users of the product should contact Richard-Allan Scientific Company for further instructions on how to proceed.

The recalled product

Product
Richard-Allan Scientific Bio-Tite Specimen Containers. 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 — Specimen Containers
Hazard
Affected units
383

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: 59601 Lot Number: 300233

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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