Recall Z-1815-2012
Tripath Imaging, Inc. · initiated March 22, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
Codes / lots: This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 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
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
FDA-determined 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.
Details
- Recall number
- Z-1815-2012
- Initiated
- March 22, 2012
- Posted by FDA
- June 15, 2012
- Terminated
- December 3, 2012
- Product code
- MKQ – Processor, Cervical Cytology Slide, Automated
- Quantity
- 46,112,784 for all products in Recall Event
- Distribution
- Worldwide Distribution.
- Recalling firm
- Tripath Imaging, Inc., Burlington, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1811-2012 Class III | PrepStain Syringing Pipettes 240 (Catalog #490517)The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1812-2012 Class III | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1813-2012 Class III | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |
| Z-1814-2012 Class III | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking.… | 03/22/2012Terminated |