HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
This recall has been terminated (originally issued December 16, 2013).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- November 15, 2013
- Posted
- December 16, 2013
- Terminated
- March 25, 2014
- Recall Number
- Z-0515-2014
- Quantity
- 6504 kits
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Distribution
Nationwide Distribution
Lot / Code Info
All lots
Root Cause
No Marketing Application
Action Taken
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.