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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62117
Product Type Devices
Status Ongoing
Recalling Firm Tripath Imaging, Inc.
City Burlington
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-08
Initial Firm Notification of
Consignee or Public
Letter
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).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671. Class II 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. 1166 units Z-2088-2012
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. 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. Class II 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. 201 units Z-2087-2012
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. 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. Catalog # 491074: Serial/Lot # 110805MA Class II 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. 1274 units Z-2086-2012
PrepStain Kit: 1.2 DiTi Cone. 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. Catalog # 490670: These items are not serially tracked. Class II 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. 18 units Z-2085-2012
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