The Recall Desk
ModerateFDA (Devices)·Z-1748-2014·Announced 2014-06-18

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.

What this means for you

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
Category
Medical Device — Diagnostic Reagent
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.

Related recalls

Same hazard · performance defect

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