The Recall Desk
ModerateFDA (Devices)·Z-2408-2021·Announced 2021-09-08

FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall involving unauthorized distribution to non-certified laboratories. No illnesses, injuries, or deaths reported; the issue involves regulatory non-compliance regarding laboratory certification requirements rather than inherent product defect.

Plain-English summary

Versea Diagnostics LLC recalled 563,290 FaStep COVID-19 IgG/IgM Rapid Test Devices distributed nationwide across 22 U.S. states. These devices are intended to detect and differentiate antibodies to SARS-CoV-2 in blood samples, indicating recent or prior COVID-19 infection.

The devices were authorized under Emergency Use guidelines for use only in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), such as CLIA-waived facilities. However, the devices were distributed to some customers who did not hold the required laboratory certification, potentially allowing untrained or unqualified individuals to perform testing.

The FDA classified this as a Class II recall. If you received COVID-19 testing using these devices, verify that the testing was performed at a CLIA-certified laboratory. If you have questions about where your testing was performed or the reliability of your results, contact your healthcare provider.

The recalled product

Product
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
Manufacturer
Versea Diagnostics LLC
Category
Medical Device — Diagnostic / Rapid Test
Hazard
Affected units
563,290

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Versea Diagnostics LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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