Billerica, MA, United States
PROTERIXBIO recalls
1 recall recorded since 2018, most recently on 17 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 April 2022
- Terminated
- 23 January 2024
- Reason
- 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).
- Distribution
- Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1058-2022
- ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.