FDAFDA · Food and drugs·Recall number Z-1346-2014
Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
Published April 16, 2014 · Recall initiated: March 4, 2014
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
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LumiQuick Diagnostics Inc.
- Distributor
- Distributed in the states of CA, FL, NJ, TX, and NY.
- Lot
- Catalog number: 71033, All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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