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Tissue-Tek Prisma®
SAKURA FINETEK U.S.A., INC. · Model 6190 · UDI-DI 00615233000040
5
510(k) clearances
3
Adverse events
2
Recalls
26
Facilities
Description
H&E Stain Kit #1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-26 | EMD Millipore Corporation | This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink. |
| 2008-06-02 | EMD Chemicals Inc | Two complaints that kit was not performing properly with positive controls. |
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Get your free API keyRead the docsData 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.