Qiagen Sciences LLC: Device Recall

Recall #Z-1504-2025 · 03/12/2025

Class II: Risk

Recall Details

Recall Number: Z-1504-2025
Classification: Class II
Product Type: Device
Recalling Firm: Qiagen Sciences LLC
Status: Ongoing
Date Initiated: 03/12/2025
Location: Germantown, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 445 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Other Recalls by Qiagen Sciences LLC

Class II: Risk 06/03/2024

Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.

View all recalls by Qiagen Sciences LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.