Recall Z-1748-2014— Sakura Finetek USA Inc

Class II · Terminated

Class II FDA medical device recall by Sakura Finetek USA Inc, initiated 2014-04-16, terminated 2014-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.. Reason: This Lot has variations in melting temperature..

Recalling firm
Sakura Finetek USA Inc
Classification
Class II
Status
Terminated
Initiated
2014-04-16
Terminated
2014-09-02
Firm location
Torrance, CA, United States

Product description

Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

Reason for recall

This Lot has variations in melting temperature.

Data sourced from openFDA. This site is unofficial and independent of the FDA.