HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
FDA Recall Z-0516-2014 · Posted 2013-12-16
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Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGGN
Date Initiated2013-11-15
Date Terminated2014-03-25
Product Quantity84561 kits
Reason for Recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K021024HEMOSIL HIGH ABNORMAL CONTROL ASSAYEDInstrumentation Laboratory CO · 2002-05-16K021022HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)Instrumentation Laboratory CO · 2002-05-14K021023HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)Instrumentation Laboratory CO · 2002-05-14
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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