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RICHARD-ALLAN SCIENTIFIC COMPANY · Model 10% Neutral Buffered Formalin Prefilled Container · UDI-DI 00673693078313
10
510(k) clearances
40
Adverse events
2
Recalls
35
Facilities
Description
10% Neutral Buffered Formalin Prefilled Containers were designed to provide safe, cost-effective transportation, storage, and retrieval of pathology specimens. Prefilled specimen containers are non-sterile clear containers with screw-top lids. Each container is prefilled with 10% Neutral Buffered Formalin which is the industry standard for tissue fixation. The 10% Neutral Buffered Formalin is the traditional formulation for phosphate-buffered formalin. Size and Quantity: 64 per case. 180 mL filled to 120 mL. Total: 7.7 Liters
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.