ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Reported: May 18, 2022 Initiated: April 17, 2022 #Z-1058-2022
Product Description
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Reason for Recall
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).
Details
- Recalling Firm
- PROTERIXBIO
- Units Affected
- 640 kits
- Distribution
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number. Recalled by PROTERIXBIO. Units affected: 640 kits.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1058-2022.
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