The Recall Desk
ModerateFDA (Devices)·Z-2407-2021·Announced 2021-09-08

COVID-19 diagnostic test distributed outside certified laboratory channels

CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.

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: This is a Class II device recall for a distribution compliance issue where products reached non-CLIA-certified customers in violation of the Emergency Use Authorization. The hazard is regulatory non-compliance rather than a product defect.

Plain-English summary

Versea Diagnostics LLC is recalling CareStart COVID-19 Antigen Rapid Diagnostic Test units distributed nationwide. The recall affects 563,290 units across multiple states including California, Florida, New York, and Texas.

The product's Emergency Use Authorization restricts use to Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories only. Products may have been distributed to customers not certified under CLIA, violating the authorization's terms.

Any non-CLIA-certified laboratory or organization that received this product should ensure it is not used. The product is intended for use only in CLIA-certified facilities.

The recalled product

Product
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by thei
Manufacturer
Versea Diagnostics LLC
Category
Medical Device — Diagnostic Test
Hazard
  • misuse-risk

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.

Related recalls

Same category