FDA Device recall Z-1504-2025

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

FDA Device
Class II
ongoing
Published 2025-04-09

On 2025-04-09 the FDA classified a Class II recall of Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a by Qiagen Sciences, citing identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1504-2025
Classification	Class II
Status	ongoing
Initiated	2025-03-12
Published	2025-04-09
Last updated	2026-09-13 11:57 UTC
Company	Qiagen Sciences
Distribution	AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, TX

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.

Identifiers

code_info	REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 3321689… REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 332168964 332168972 332168978 332168979 332168980 332168990 332168996 332169005 332169012 332169013 332169015 332169016 332169021 332169022 332169023 332169024 332169031 332169032 332169033 332169034 332169039 332169040 332169041 332169042 332169047 332169048 332169049 332169050 332169055 332169056 332169057 332169060 332169065 332169066 332169073 332169074 332169083 332169084 332169085 332169086 332169091 332169092 332169093 332169094 332169099 332169101 332169102 332169107 332169108 332169109 332169110 332169115 332169116 332169117 332169118 332169123 332169125 332169126 332169131 332169132 332169133 332169134 332169139 332169140 332169141 332169142 332169147 332169148 332169149 332169150 332169155 332169156 332169157 332169158 332169163 332169164 332169165 332169166 332169171 332169172 332169173 332169174 332169180 332169181 332169182 332169187 332169188 332169189 33216919

code_info

REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 3321689…

REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 332168961 332168962 332168963 332168964 332168972 332168978 332168979 332168980 332168990 332168996 332169005 332169012 332169013 332169015 332169016 332169021 332169022 332169023 332169024 332169031 332169032 332169033 332169034 332169039 332169040 332169041 332169042 332169047 332169048 332169049 332169050 332169055 332169056 332169057 332169060 332169065 332169066 332169073 332169074 332169083 332169084 332169085 332169086 332169091 332169092 332169093 332169094 332169099 332169101 332169102 332169107 332169108 332169109 332169110 332169115 332169116 332169117 332169118 332169123 332169125 332169126 332169131 332169132 332169133 332169134 332169139 332169140 332169141 332169142 332169147 332169148 332169149 332169150 332169155 332169156 332169157 332169158 332169163 332169164 332169165 332169166 332169171 332169172 332169173 332169174 332169180 332169181 332169182 332169187 332169188 332169189 33216919

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1504-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.