# P970018: BD Prepstain System

- Pathway: PMA
- Applicant: Bd Diagnostic Systems
- Decided: Jun 17, 1999 after 766 days
- Product code: MKQ (Processor, Cervical Cytology Slide, Automated)
- Device class: 3
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 12, 2016 · Class II · Z-0877-2017: 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.
- Mar 22, 2012 · Class III · Z-1811-2012: 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
- Mar 22, 2012 · Class III · Z-1812-2012: 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
- Mar 22, 2012 · Class III · Z-1815-2012: 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
- Mar 22, 2012 · Class III · Z-1814-2012: 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
- Mar 22, 2012 · Class III · Z-1813-2012: 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
- Dec 8, 2011 · Class II · Z-2085-2012: 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.
- Dec 8, 2011 · Class II · Z-2087-2012: 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.
- Dec 8, 2011 · Class II · Z-2088-2012: 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.
- Dec 8, 2011 · Class II · Z-2086-2012: 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.
- Sep 26, 2008 · Not classified · Z-1090-2009: 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.

Source page: https://510kreport.com/device/P970018
Methodology: https://510kreport.com/methodology