Versea Diagnostics LLC: Medical Device Recall in 2021 - (Recall #: Z-2407-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories)

Product Classification:

Class II

Date Initiated: July 27, 2021

Date Posted: September 8, 2021

Recall Number: Z-2407-2021

Event ID: 88429

Reason for Recall:

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

Status: Terminated

Product Quantity: 563,290 in total

Code Information:

all lot codes

Distribution Pattern:

US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated