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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Recall Number Z-0515-2014
Classification Class II
Code Info All lots
Product Distributed Qty 6504 kits
Reason For Recall HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Event Detail

Event Id 66894
Product Type Devices
Status Ongoing
Recalling Firm Instrumentation Laboratory Co.
City Bedford
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution