FDA recall Z-1420-2021

Product

Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

Reason for recall

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Distribution

US: LA, TX, FL, GA

Key facts

Status

Terminated

Initiation date

2021-03-11

Report date

2021-04-21

Termination date

2022-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1420-2021