FDA-Device2023-06-14Class II

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

Qiagen Sciences LLC
Hazard

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

Sold states
US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
Affected count
347 kits
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Official notice

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

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