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Epredia
RICHARD-ALLAN SCIENTIFIC COMPANY · Model Modified EA Papanicolaou Stain · UDI-DI 00673693088404
10
510(k) clearances
0
Adverse events
2
Recalls
30
Facilities
Description
Modified EA is used in conjunction with OG-6 or Modified OG for gynecological and non-gynecological specimens. This formulation does not contain Bismarck Brown and is optimized to reduce precipitate formation that is common with other traditional EA formulations. The Modified EA staining results are most similar to EA-50.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-19 | Richard-Allan Scientific Company | The 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 |
| 2002-12-13 | EMD Chemicals Inc | Difficulty in reading slides due to the stain is much greener than normal. |
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