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.
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 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.
- Manufacturer
- Richard-Allan Scientific Company
- Hazard
- 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
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.
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