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Tissue-Tek Xpress®

SAKURA FINETEK U.S.A., INC. · Model 7150 · UDI-DI 00615233081568

KEOLDZ
10
510(k) clearances
1
Adverse events
3
Recalls
24
Facilities

Description

Processing Reagent Set, Formula 3

Recalls

DateFirmReason
2014-04-16Sakura Finetek USA IncThis Lot has variations in melting temperature.
2010-01-22Abbott MolecularThe Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
2010-01-22Abbott MolecularThe Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.