Recall archive / FDA device enforcement
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model ... — FDA record Z-1058-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
- 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).
- Classification
- Class II
- Recalling firm
- PROTERIXBIO
- Quantity
- 640 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-1058-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots were not coded. All product will be recalled. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 18, 2022
- Recall initiation date
- Apr 17, 2022
- Center classification date
- May 11, 2022
- Termination date
- Jan 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.