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RICHARD-ALLAN SCIENTIFIC COMPANY · Model Periodic Acid-Schiff Stain Kit · UDI-DI 00673693089173

HZT
5
510(k) clearances
3
Adverse events
2
Recalls
26
Facilities

Description

"Periodic Acid-Schiff Stain Kit is a staining kit used to detect carbohydrates, glycogen, basement membranes, and fungus in tissue sections for the diagnosis of general pathology specimens. Periodic acid oxidizes these various tissue moieties to aldehydes, to which Schiff Reagent bonds in its colorless form. Rinsing with water removes the sulfurous acid and restores the Schiff Reagent to its rose-colored form."

Recalls

DateFirmReason
2024-01-26EMD Millipore CorporationThis IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
2008-06-02EMD Chemicals IncTwo complaints that kit was not performing properly with positive controls.

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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.