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REMEL
REMEL, INC. · Model R21641 · UDI-DI 00848838024054
10
510(k) clearances
39
Adverse events
2
Recalls
35
Facilities
Description
Formalin 10% (15ml) PK/288
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-13 | Richard-Allan Scientific Company | potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigen |
| 2008-05-01 | ThermoFisher Scientific Co., LLC | Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%. |
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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.