Recall Z-0516-2014
Instrumentation Laboratory Co. · initiated November 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Codes / lots: All lots
Reason for recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
FDA-determined 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.
Details
- Recall number
- Z-0516-2014
- Initiated
- November 15, 2013
- Posted by FDA
- December 16, 2013
- Terminated
- March 25, 2014
- Product code
- GGN – Plasma, Coagulation Control
- Quantity
- 84561 kits
- Distribution
- Nationwide Distribution
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0514-2014 Class II | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 11/15/2013Terminated |
| Z-0515-2014 Class II | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 11/15/2013Terminated |