FDAFDA · Food and drugs·Recall number Z-1058-2022
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Published May 18, 2022 · Recall initiated: April 17, 2022
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
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PROTERIXBIO
- Distributor
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Lot
- Lots were not coded. All product will be recalled.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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