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ThinPrep 5000 Processor

Hologic, Inc. · Model ThinPrep 5000 Processor · UDI-DI 15420045504158

MKQ Prescription

510(k) clearances

410

Adverse events

Recalls

Facilities

Description

Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.

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 leaking of the preserv
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 leaking syringing p
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 leaking syringing p
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 leaking syringing p
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 leaking syringing p
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 leaking syringing p
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.