| | Class 3 Recall
PrepStain Syringing Pipettes |  |
| Date Posted |
June 15, 2012 |
| Recall Number |
Z-1811-2012 |
| Product |
PrepStain Syringing Pipettes 240 (Catalog #490517) |
| Code Information |
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
|
Recalling Firm/
Manufacturer |
Tripath Imaging, Inc.
780 Plantation Dr
Burlington, North Carolina 27215-6723 |
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
|
| 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. |
| Distribution |
Worldwide Distribution. |
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