FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
- Recall number
- Z-0516-2014
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
- Status
- Terminated
- Initiated
- 2013-11-15
- Posted
- 2013-12-16
- Terminated
- 2014-03-25
- Reason
- HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
- Root cause
- 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
- 84561 kits
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K021022","K021023","K021024"]
- PMA numbers
- not on file
- Product code
- GGN
- Firm FEI
- 1217183
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28