Sakura Finetek Recalls Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 Due to Melting Variations
Sakura Finetek USA Inc is recalling 115 units of Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 because the lot has variations in melting temperature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, and the hazard involves a performance defect (melting temperature variation) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Sakura Finetek USA Inc is recalling 115 units of Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 (Product Code 7052, Lot Number 263922). The product is a diagnostic chemistry medium distributed nationwide.
The recall was initiated because the specific lot has variations in melting temperature. This defect may affect the performance of the product for its intended diagnostic use.
Users of this product should stop using the affected lot and contact Sakura Finetek USA Inc for further instructions or a replacement.
The recalled product
- Product
- Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
- Manufacturer
- Sakura Finetek USA Inc
- Hazard
- Affected units
- 115
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: 7052. Lot Number: 263922.
Distribution
Distributed nationwide across the United States.
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