BD PrepStain 490521

• 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.