# FDA recall Z-1058-2022

> **PROTERIXBIO** · Class II · device recall initiated 2022-04-17.

## Product

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

Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA

## Key facts

- **Recall number:** Z-1058-2022
- **Recalling firm:** PROTERIXBIO
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-17
- **Report date:** 2022-05-18
- **Termination date:** 2024-01-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2022

## Citation

> AI Analytics. FDA recall Z-1058-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1058-2022. Source: US FDA. Licensed CC0.

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