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U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL High Abnormal Control 3 UNASSAYED

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 Class 2 Recall
HemosIL High Abnormal Control 3 UNASSAYED
see related information
Date Posted December 16, 2013
Recall Status1 Terminated on March 25, 2014
Recall Number Z-0516-2014
Recall Event ID 66894
Premarket Notification
510(K) Numbers
K021022  K021023  K021024 
Product Classification Plasma, Coagulation Control - Product Code GGN
Product HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Code Information All lots
Recalling Firm/
Manufacturer
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford, Massachusetts 01730-2443
Manufacturer Reason
for Recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email. An enclosed response tracking form provided to be returned. For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products). For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6. For questions regarding this recall call 781-861-4467.
Quantity in Commerce 84561 kits
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GGN and Original Applicant = INSTRUMENTATION LABORATORY CO.
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