Z-1058-2022 Class II Terminated
FDA device recall Z-1058-2022 was initiated by PROTERIXBIO on April 17, 2022 and is designated Class II. 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). The recall status is terminated (terminated January 23, 2024). Affected quantity: 640 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 17, 2022
- Termination Date
- January 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 640 kits
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).
Distribution Pattern
Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Code Information
Lots were not coded. All product will be recalled.