Home / Recalls / Tripath Imaging, Inc. / Z-1814-2012

Z-1814-2012 Class III Terminated

Recalled by Tripath Imaging, Inc. — Burlington, NC

Recall Details

Product Type
Devices
Report Date
June 27, 2012
Initiation Date
March 22, 2012
Termination Date
December 3, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,112,784 for all products in Recall Event

Product Description

Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

Reason for Recall

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

Distribution Pattern

Worldwide Distribution.

Code Information

100903ru, 100924rr, 101022sc, 110114sh, 110225ru

Other recalls by Tripath Imaging, Inc.

  • Z-1811-2012 Class III — PrepStain Syringing Pipettes 240 (Catalog #490517) (March 22, 2012)
  • Z-1812-2012 Class III — PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 (March 22, 2012)
  • Z-1813-2012 Class III — PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 (March 22, 2012)
  • Z-1815-2012 Class III — PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, pe (March 22, 2012)
  • Z-2088-2012 Class II — PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671 (December 8, 2011)
  • Z-2086-2012 Class II — PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liqui (December 8, 2011)
  • Z-2085-2012 Class II — PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin lay (December 8, 2011)
  • Z-2087-2012 Class II — PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer (December 8, 2011)