FDA (Devices) recall action 61737
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.
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.
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.
Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.
Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.
Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.