Qiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:…

Recall date: March 12, 2025
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-1504-2025
FDA classification: Class II
Brand / firm: Qiagen Sciences LLC
Sold / distributed: US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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