FDA recall Z-0134-2023

Product

ARIES SARS-CoV-2 Assay, REF: 50-10047

Reason for recall

A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.

Distribution

Distribution US nationwide, Indonesia, and Hong Kong.

Key facts

Status

Ongoing

Initiation date

2022-09-14

Report date

2022-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2023