PROTERIXBIO 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1058-2022
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood… Recall
Issued May 18, 2022 · PROTERIXBIO
In May 2022, PROTERIXBIO recalled the ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PROTERIXBIO to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- PROTERIXBIO
- Category
- Health
- Recall date
- May 18, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Recall number
- FDA-Z-1058-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- PROTERIXBIO has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.