ProterixBio SARS-CoV-2 recall
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Why was ProterixBio SARS-CoV-2 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots were not coded. All product will be recalled.
- Product
- ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
- Recalling firm
- PROTERIXBIO
- Quantity
- 640 kits
- Distribution
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)