Recall Z-2087-2012
Tripath Imaging, Inc. · initiated December 8, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: Catalog # 490100; Serial/Lot #s: USPS200576, USPS200577, USPS200578, USPS200583, USPS200584, USPS200585, USPS200586, USPS200587, USPS200588, USPS200589, USPS200590, USPS200591,USPS200592, USPS200593, USPS200594, USPS200595, USPS200596, USPS200597,USPS200598, USPS200599, USPS200600, USPS200601, USPS200602, USPS200603, USPS200604, USPS200605, USPS200606, USPS200607, USPS200608, USPS200609,USPS200610, USPS200611, USPS200612, USPS200613, USPS200614, USPS200615, USPS200616, USPS200617, USPS200618, USPS200619, USPS200620, USPS200621,USPS200622, USPS200623, USPS200624, USPS200625, USPS200626, USPS200627,USPS200628, USPS200629, USPS200630, USPS200631, USPS200632, USPS200633, USPS200634, USPS200635, USPS200636, USPS200637, USPS200638, USPS200639,USPS200640, USPS200641, USPS200642, USPS200643, USPS200644, USPS200645, USPS200646, USPS200647, USPS200648, USPS200649, USPS200650, USPS200651, USPS200652, USPS200653, USPS200654, USPS200655, USPS200656, USPS200657, USPS200658, USPS200659, USPS200660, USPS200661, USPS200662, USPS200663, USPS200664, USPS200665, USPS200666, USPS200667, USPS200668, USPS200669, USPS200670, USPS200671, USPS200672, USPS200673, USPS200674, USPS200675, USPS200676…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.
Details
- Recall number
- Z-2087-2012
- Initiated
- December 8, 2011
- Posted by FDA
- July 26, 2012
- Terminated
- November 8, 2013
- Product code
- MKQ – Processor, Cervical Cytology Slide, Automated
- Quantity
- 201 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and…
- Recalling firm
- Tripath Imaging, Inc., Burlington, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2085-2012 Class II | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-2086-2012 Class II | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |
| Z-2088-2012 Class II | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671)…Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain… | 12/08/2011Terminated |