FDAFDA · Food and drugs·Recall number Z-1109-2017
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Published February 8, 2017 · Recall initiated: December 27, 2016
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 affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Immuno-Mycologics, Inc
- Distributor
- Nationwide throughout the US
- Lot
- 161028133653JH, 161003111544KH, and 161007105036JG
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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