Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 |
|---|---|
| Recall Number | Z-1813-2012 |
| Classification | Class III |
| Code Info | 100917ry, 101105sh, 110107rg |
| Product Distributed Qty | 46,112,784 for all products in Recall Event |
| 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 |
Event Detail
| Event Id | 61737 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Tripath Imaging, Inc. |
| City | Burlington |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution. |
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