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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Recall Number Z-1814-2012
Classification Class III
Code Info 100903ru, 100924rr, 101022sc, 110114sh, 110225ru
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.