The Recall Desk

FDA (Devices) recall action 61737

Tripath Imaging, Inc. recalled 5 products on 2012-06-27

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-06-27
Critical
0
Units
230,563,920

Why these products were recalled

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

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.

1–5 of 5

  • LowFDA (Devices)··2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.

    Product
    PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-06-27

    Tripath PrepStain Installation Kit Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.

    Product
    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.

    Product
    PrepStain Syringing Pipettes 240 (Catalog #490517)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-06-27

    Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.

    Product
    PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2012-06-27

    Tripath Imaging Recalls 480 Test Kits Due to Leaking Pipettes

    Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.

    Product
    Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
    Category
    Distribution
    0 states