FDA recall Z-1683-2023

Qiagen Sciences LLC · Class II · device

Product

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Reason for recall

Faulty cartridges in the lot could result in false test results.

Distribution

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Key facts

Status
Ongoing
Initiation date
2023-04-28
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2023