FDA recall Z-1524-2022

Product

ARIES SARS-CoV-2 Assay

Reason for recall

SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Distribution

U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

Key facts

Status

Ongoing

Initiation date

2022-07-14

Report date

2022-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2022