Home › Device types › LEA
Preservative, Cytological
FDA product code LEA · Class 1 · Pathology
67
Registered devices
23
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYEpredia — RICHARD-ALLAN SCIENTIFIC COMPANYPathTezt® — BIOCYTECH CORPORATION SDN. BHD.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYThinPrep — Hologic, Inc.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYPathTezt® — BIOCYTECH CORPORATION SDN. BHD.ThinPrep® — Hologic, Inc.PathTezt® — BIOCYTECH CORPORATION SDN. BHD.ThinPrep® — Hologic, Inc.PathTezt® — BIOCYTECH CORPORATION SDN. BHD.Streck Cell Preservative — STRECK, INC.ThinPrep® — Hologic, Inc.PathTezt® — BIOCYTECH CORPORATION SDN. BHD.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYEpredia — RICHARD-ALLAN SCIENTIFIC COMPANYBD CytoRich™ Clear Preservative — BECTON, DICKINSON AND COMPANYThinPrep — Hologic, Inc.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANYEpredia — RICHARD-ALLAN SCIENTIFIC COMPANYThinPrep — Hologic, Inc.PathTezt® — BIOCYTECH CORPORATION SDN. BHD.ThinPrep® — Hologic, Inc.Epredia — RICHARD-ALLAN SCIENTIFIC COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | Hologic, Inc | Fungal contamination of affected lot with Parengyodontium album. |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal conta |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal conta |
| 2012-02-20 | Leica Biosystems Richmond Inc. | Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was |
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