Z-2087-2012 Class II Terminated
FDA device recall Z-2087-2012 was initiated by Tripath Imaging, Inc. on December 8, 2011 and is designated Class II. 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. The recall status is terminated (terminated November 8, 2013). Affected quantity: 201 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- December 8, 2011
- Termination Date
- November 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 201 units
Product Description
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.
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.
Distribution Pattern
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 Victoria (Australia).
Code Information
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, USPS200677, USPS200678, USPS200679, USPS200680, USPS200681, USPS200682, USPS200683, USPS200684, USPS200685, USPS200686, USPS200687, USPS200688, USPS200689, USPS200690, USPS200691, USPS200692, USPS200693, USPS200694, USPS200695, USPS200696, USPS200697, USPS200698, USPS200699, USPS200701, USPS200702, USPS200703, USPS200704, USPS200705, USPS200706, USPS200707, USPS200708, USPS200709, USPS200710, USPS200711, USPS200712, USPS200713, USPS200714, USPS200715, USPS200716, USPS200717, USPS200718, USPS200719, USPS200720, USPS200721, USPS200722, USPS200723, USPS200724, USPS200725, USPS200726, USPS200727, USPS200728, USPS200729, USPS200730, USPS200731, USPS200732, USPS200733, USPS200734, USPS200735, USPS200736, USPS200737, USPS200738, USPS200739, USPS200740, USPS200741, USPS200742, USPS200743, USPS200744, USPS200746, USPS200748, USPS200751, USPS200756, USPS200757, USPS200758, USPS200759, USPS200760, USPS200761, USPS200762, USPS200763, USPS200764, USPS200765, USPS200766, USPS200767, USPS200768, USPS200769, USPS200770, USPS200771, USPS200772, USPS200773, USPS200774, USPS200775, USPS200776, USPS200777, USPS200778, USPS200781, USPS200783 and USPS200787.