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Recall Observatory FDA recall evidence

Device product

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

Z-1748-2014

April 16, 2014

Class II

Product summary

Firm
Sakura Finetek USA Inc
Event
Event 68081
Status
Terminated
Classification
Class II
Quantity
115
Official record key
device-enforcement:Z-1748-2014

Official wording

Reason: This Lot has variations in melting temperature.

Code information: Product Code: 7052. Lot Number: 263922.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This Lot has variations in melting temperature.