FDAFDA · Food and drugs·Recall number Z-0516-2014
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Published December 25, 2013 · Recall initiated: November 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumentation Laboratory Co.
- Distributor
- Nationwide Distribution
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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