Z-1813-2012 Class III Terminated
FDA device recall Z-1813-2012 was initiated by Tripath Imaging, Inc. on March 22, 2012 and is designated Class III. 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 The recall status is terminated (terminated December 3, 2012). Affected quantity: 46,112,784 for all products in Recall Event.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2012
- Initiation Date
- March 22, 2012
- Termination Date
- December 3, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46,112,784 for all products in Recall Event
Product Description
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
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 Pattern
Worldwide Distribution.
Code Information
100917ry, 101105sh, 110107rg