Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | 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) |
|---|---|
| Recall Number | Z-1815-2012 |
| Classification | Class III |
| Code Info | 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 |
| 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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