PROTERIXBIO recalls ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
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).
Read the official notice →- Date
- 2022-05-18
- Country
- United States
- Brand
- PROTERIXBIO
- Product
- ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
- Classification
- Class II
- Units
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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