Epredia
RICHARD-ALLAN SCIENTIFIC COMPANY · Model EA-50 Papanicolaou Stain · UDI-DI 00673693228527
Description
EA-36, -50, -65 and Modified EA are ready-to-use cytoplasmic counterstains used for gynecological and non-gynecological cytology specimens. These products contain common dyes and reagent solvents used in traditional EA formulations. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results. Cellular results are traditional as well, with basal or intermediate cells staining a blue-green hue and surface cells staining a pink-red hue. This multicolored effect is due to dye uptake by various cells and their affinities for the specific dyes. EA 50 is used in conjunction with OG-6 for the staining of gynecological specimens. It will provide a very traditional staining result with common staining hues and intensities. EA-50 can also be used for non-gynecological specimens however, although EA-65 is recommended.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-07 | Becton Dickinson & Co. | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level |
| 2026-04-07 | Becton Dickinson & Co. | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level |
| 2010-08-13 | Becton Dickinson & Co. | In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples. |
| 2005-11-23 | Becton Dickinson & Co. | Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs