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BD PrepStain System

by Bd Diagnostic Systems PMA

Active United States

PMA P970018

Overview

The BD PrepStain System is an automated processor for cervical cytology slide preparation, classified as a liquid-based, thin-layer cell preparation device. It generates slides designed to replace conventional gynecologic Pap smears, enabling screening and detection of cervical cancer, precancerous lesions, atypical cells, and other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.

This system is intended for use in pathology settings and operates as a single-use, non-sterile device. It requires no specific MRI safety considerations and is supplied as a complete kit for automated slide processing. Authorized under FDA PMA (P970018), the system adheres to regulatory standards for cervical cytology slide preparation and is distributed under product code MKQ.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP970018 Date17 Jun 1999ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

11 recalls · FDA

    • Terminated Z-0877-2017 FDA Class II initiated 12 Feb 2016

    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 preservative fluid.

  • 5 recalls, same reason

    • Terminated Z-1815-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1813-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1811-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1814-2012 FDA Class III initiated 22 Mar 2012
    • Terminated Z-1812-2012 FDA Class III initiated 22 Mar 2012

    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 pipettes

  • 4 recalls, same reason

    • Terminated Z-2085-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2087-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2088-2012 FDA Class II initiated 8 Dec 2011
    • Terminated Z-2086-2012 FDA Class II initiated 8 Dec 2011

    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.

    • Terminated Z-1090-2009 FDA Unclassified (pre-2012) initiated 26 Sep 2008

    Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.

Specification

PMA

Generic Name
Processor, cervical cytology slide, automated
PMA Number
FDA Product Code
MKQ
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

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