FDAFDA · Food and drugs·Recall number Z-0387-2018
Phadia 1000 Instrument, Article Number 12-3800-01.
Published January 24, 2018 · Recall initiated: July 5, 2017
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
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Phadia US Inc
- Distributor
- Nationwide
- Lot
- All versions of the instrument
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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