PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

Class I - Dangerous

🏥 Medical Devices Recalled: March 22, 2012 Tripath Imaging Other Medical Devices

What Should You Do?

Check if you have this product:
100917ry, 101105sh, 110107rg
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Tripath Imaging, Inc.
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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

Product Codes/Lot Numbers:

100917ry, 101105sh, 110107rg

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1813-2012

Related Recalls

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 cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.

Tripath Imaging

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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.

Dec 8, 2011 Other Medical Devices Nationwide View Details →

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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.

Dec 8, 2011 Other Medical Devices Nationwide View Details →

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Tripath Imaging

Class I - Dangerous

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.

Dec 8, 2011 Other Medical Devices Nationwide View Details →