CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report

QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative recalled

Qiagen is recalling QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative test intended for analyzing, distributed in 14 states. The recall was initiated on 19 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17

Quantity recalled386 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2245-2023
FDA event ID: 92609
Recalling firm: Qiagen, Hilden, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 19 May 2023
FDA classified: 27 Jul 2023
Reported: 2 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

19 May 2023	Recall initiated by company
27 Jul 2023	Classified by FDA	+69 days
2 Aug 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Product as listed by the FDA

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

Where it was distributed

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

Alabama California District of Columbia Delaware Florida Georgia Idaho Indiana Maine North Carolina New York Oregon Tennessee Texas

Questions about this recall

Why was it recalled?

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Which lots are affected?

GTIN 14053228038846 LOT Numbers: 175010704, 175011354 Exp. Date: 2023-10-06 and 2023-10-17

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92609

Reported	Class	Recall	Company	Reason	Where
2 Aug 2023	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD recalled	Qiagen	Other	14 states

More recalls from Qiagen

All 6

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Device	CLASS II	therascreen ¿KRAS RGQ PCR Kit -IVD qualitative PCR assay recalled	Qiagen	Lead & Heavy Metals	Nationwide
2 Aug 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD recalled	Qiagen	Other	14 states
2 Aug 2023Device	CLASS II	QIAstat-Dx¿ Respiratory Sars-CoV-2 Panel -IVD intended recalled	Qiagen	Lead & Heavy Metals	17 states
8 Aug 2018Device	CLASS II	EZ1 DSP Virus Kit , IVD recalled by QIAGEN	QIAGEN	Lead & Heavy Metals	Nationwide
27 Dec 2017Device	CLASS II	QIAamp DSP Virus Kit recalled by Qiagen	Qiagen	Other	AR, DE, IN

Other CPAP & Ventilators recalls

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2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide