FDA recall Z-1504-2025

Qiagen Sciences LLC · Class II · device

Product

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

Reason for recall

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

Distribution

US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.

Key facts

Status
Ongoing
Initiation date
2025-03-12
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2025