FDA Device Intelligence
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Processor, Cervical Cytology Slide, Automated

FDA product code MKQ · Class 3 · Unknown

70
Registered devices
411
Adverse events
29
Recalls
0
510(k) clearances

Devices with this code

BD PrepStain™ Slide Library Kit — BECTON, DICKINSON AND COMPANYBD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON, DICKINSON AND COMPANYSurePath Preservative Fluid Collection Vial — BECTON, DICKINSON AND COMPANYBD Totalys™ SlidePrep Slide Library Kit — TRIPATH IMAGING, INC.BD PrepMate™ Automated Accessory — BECTON, DICKINSON AND COMPANYThinPrep — Hologic, Inc.BD SurePath — BECTON, DICKINSON AND COMPANYBD SurePath — TRIPATH IMAGING, INC.BD PrepMate™ Automated Accessory — BECTON, DICKINSON AND COMPANYBD Totalys SlidePrep — BECTON, DICKINSON AND COMPANYBD PrepStain™ Consumables Kit — TRIPATH IMAGING, INC.BD Settling Chambers — TRIPATH IMAGING, INC.BD SurePath — BECTON, DICKINSON AND COMPANYBD SurePath — TRIPATH IMAGING, INC.BD PrepStain™ Consumables Kit — BECTON, DICKINSON AND COMPANYThinPrep Pap Test — Hologic, Inc.ThinPrep Pap Test — Hologic, Inc.BD SurePath — TRIPATH IMAGING, INC.ThinPrep 2000 Processor — Hologic, Inc.BD Totalys™ MultiProcessor Consumables Kit — TRIPATH IMAGING, INC.ThinPrep 5000 Processor — Hologic, Inc.BD Totalys™ MultiProcessor Installation Kit — BECTON, DICKINSON AND COMPANYBD Settling Chambers — TRIPATH IMAGING, INC.ThinPrep — Hologic, Inc.

Recent recalls

DateFirmReason
2016-02-12Becton Dickinson & Co.BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to le
2013-07-08Becton Dickinson & Co.PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative
2013-07-08Becton Dickinson & Co.PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative
2013-07-08Becton Dickinson & Co.PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative
2012-03-22Tripath Imaging, Inc.The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of
2012-03-22Tripath Imaging, Inc.The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of
2012-03-22Tripath Imaging, Inc.The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of
2012-03-22Tripath Imaging, Inc.The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of
2012-03-22Tripath Imaging, Inc.The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of
2011-12-08Tripath Imaging, Inc.Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.