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ThinPrep® Pap Test

Hologic, Inc. · Model ThinPrep® Pap Test PreservCyt® Sol'n 20ml · UDI-DI 15420045501072

MKQ Prescription

510(k) clearances

410

Adverse events

Recalls

Facilities

Description

For use with the ThinPrep® system to preserve gynecological specimens.

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.