Recall Z-1812-2012 ยท MKQ Processor, Cervical Cytology Slide, Automated
Tripath Imaging, Inc.
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
| Date | Jun 15, 2012 (initiated Mar 22, 2012) |
| Status | Terminated |
| Reason | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Root cause | Component design/selection |
| Action | BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice. |
| Quantity | 46,112,784 for all products in Recall Event |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.