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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Modified OG Papanicolaou Stain · UDI-DI 00673693088282

HZJ
10
510(k) clearances
0
Adverse events
2
Recalls
30
Facilities

Description

Modified OG is used in conjunction with EA products for staining gynecological and non-gynecological specimens. This formulation is optimized to reduce precipitate formation and staining times common with traditional OG-6 formulations. Modified OG and Modified EA, when used together, will reduce filtering and staining times.

Recalls

DateFirmReason
2015-02-19Richard-Allan Scientific CompanyThe case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and
2002-12-13EMD Chemicals IncDifficulty in reading slides due to the stain is much greener than normal.

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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.