Home › Device types › MKQ

Processor, Cervical Cytology Slide, Automated

FDA product code MKQ · Class 3 · Unknown

Registered devices

410

Adverse events

Recalls

510(k) clearances

Devices with this code

ThinPrep® Pap Test — Hologic, Inc.BD SurePath™ Manual Method Kit — BECTON, DICKINSON AND COMPANY BD SurePath — TRIPATH IMAGING, INC.BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON, DICKINSON AND COMPANY BD PrepMate™ Installation Kit — BECTON, DICKINSON AND COMPANY ThinPrep 5000 Processor — Hologic, Inc.ThinPrep — Hologic, Inc.BD PrepStain Slide Processor — TRIPATH IMAGING, INC.ThinPrep 2000 Processor — Hologic, Inc.BD SurePath — TRIPATH IMAGING, INC.BD PrepStain — TRIPATH IMAGING, INC.BD Density Reagent — TRIPATH IMAGING, INC.ThinPrep 5000 Processor — Hologic, Inc.BD PrepMate™ Consumables Kit — BECTON, DICKINSON AND COMPANY ThinPrep Pap Test — Hologic, Inc.BD SurePath™ Collection Vial Kit 25 — TRIPATH IMAGING, INC.ThinPrep® Pap Test — Hologic, Inc.BD Settling Chambers — TRIPATH IMAGING, INC.BD PrepStain™ Consumables Kit — TRIPATH IMAGING, INC.PrepStain® Syringing Pipettes — TRIPATH IMAGING, INC.BD SurePath — BECTON, DICKINSON AND COMPANY BD PrepStain Slide Processor — BECTON, DICKINSON AND COMPANY BD SurePath™ PreCoat Slides — BECTON, DICKINSON AND COMPANY ThinPrep — Hologic, Inc.

Recent recalls

Date	Firm	Reason
2016-02-12	Becton 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
2013-07-08	Becton 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
2013-07-08	Becton 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
2013-07-08	Becton 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
2012-03-22	Tripath 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
2012-03-22	Tripath 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
2012-03-22	Tripath 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
2012-03-22	Tripath 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
2012-03-22	Tripath 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
2011-12-08	Tripath 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.