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 (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.
- 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:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). 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.
Product Codes/Lot Numbers:
SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2088-2012
Related Recalls
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.
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.
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.