QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Reported: August 2, 2023 Initiated: May 19, 2023 #Z-2245-2023
Product Description
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Reason for Recall
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Details
- Recalling Firm
- Qiagen GmbH
- Units Affected
- 386 kits
- Distribution
- DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA
- Location
- Hilden, N/A
Frequently Asked Questions
What product was recalled? ▼
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223. Recalled by Qiagen GmbH. Units affected: 386 kits.
Why was this product recalled? ▼
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2245-2023.
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