The Recall Desk

FDA (Devices) recall action 62117

Tripath Imaging, Inc. recalled 4 products on 2012-08-01

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2012-08-01
Critical
0
Units
2,659

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2012-08-01

    Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical
    Category
    Distribution
    48 states
  • ModerateFDA (Devices)··2012-08-01

    Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (49042
    Category
    Distribution
    48 states
  • ModerateFDA (Devices)··2012-08-01

    Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions

    Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all ot
    Category
    Distribution
    48 states
  • ModerateFDA (Devices)··2012-08-01

    Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other
    Category
    Distribution
    48 states