Medical device manufacturer, BD Diagnostics, has issued a field safety notice concerning BD PrepMate™ Syringing Pipette shipped between 31 August 2010 and March 2012. The affected devices can be found in the following products:
| Product Name | Catalog No. |
|---|---|
| BD PrepStain™ GYN 480 Disposable Kit | 490542 |
| BD PrepStain™ Suringing Pipettes 240 | 490517 |
| BD PrepStain™ GYN 480 Disposable Test Kit with PreCoat Slides | 490523 |
| BD PrepStain™ Installation Kit (PreCoat) | 490528 |
| Manual Method 1:480 Test Kit (PreCoat) | 490529 |
According to BD, the affected devices may leak and decrease the dispensing volume of the sample. The root cause is determined to be a dimensional issue with the barrel of the syringe. Age of the device may also be a factor in relation to the leaking. BD observed that a leaking pipette is usually at least 6 months old, while some can be as early as 4 months old.
BD recommends the affected users to refer to the Operator's Manual and inspect the centrifuge tubes so as to make sure correct amount of sample has been transferred. If a pipette is found to be defective, users are suggested to discard the pipette and contact BD for replacement.
According to the local supplier, the affected devices have been distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.