FDAFDA · Food and drugs·Recall number Z-3185-2024
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Published September 25, 2024 · Recall initiated: August 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cypress Medical Products LLC
- Distributor
- US Nationwide distribution.
- Lot
- GTIN: 10815845020031; All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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