Recall Z-2085-2012 ยท MKQ Processor, Cervical Cytology Slide, Automated
Tripath Imaging, Inc.
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
| Date | Jul 26, 2012 (initiated Dec 8, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 18 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.