Recall Z-1504-2025— Qiagen Sciences LLC
Class II · Ongoing
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2025-03-12. It names one FDA 510(k) clearance: K233100. Product: Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a. Reason: Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-12
- Firm location
- Germantown, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.