FDA recall Z-2245-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-05-19

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hilden, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2245-2023