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

QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD recalled

Qiagen is recalling QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not, 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 codesLOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17

Quantity recalled4155 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-2246-2023
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 (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

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?

LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 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

This product is part of a recall event; the main page for the event is QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative recalled.

Reported	Class	Recall	Company	Reason	Where
2 Aug 2023	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative recalled	Qiagen	Other	14 states

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2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
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5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
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