PrepStain Syringing Pipettes 240 (Catalog #490517)
This recall has been terminated (originally issued June 15, 2012).
- Company
- Tripath Imaging, Inc.
- Recall Initiated
- March 22, 2012
- Posted
- June 15, 2012
- Terminated
- December 3, 2012
- Recall Number
- Z-1811-2012
- Quantity
- 46,112,784 for all products in Recall Event
- Firm Location
- Burlington, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution.
Lot / Code Info
100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r
Root Cause
Component design/selection
Action Taken
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.