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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 All lots Class II HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 80319 Kits Z-0514-2014
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 All lots Class II HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 84561 kits Z-0516-2014
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 All lots Class II HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 6504 kits Z-0515-2014
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