Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Reported: April 9, 2025 Initiated: March 12, 2025 #Z-1504-2025
Product Description
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.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 445 units
- Distribution
- US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a. Recalled by Qiagen Sciences LLC. Units affected: 445 units.
Why was this product recalled? ▼
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1504-2025.
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