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

QIAstat-Dx¿ Respiratory Sars-CoV-2 Panel -IVD intended recalled

Qiagen is recalling QIAstat-Dx¿ Respiratory Sars-CoV-2 Panel -IVD intended for the detection and, distributed in 17 states. The recall was initiated on 9 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783

Quantity recalled368 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-2215-2023
FDA event ID: 92540
Recalling firm: Qiagen, Hilden, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 9 May 2023
FDA classified: 21 Jul 2023
Reported: 2 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

9 May 2023	Recall initiated by company
21 Jul 2023	Classified by FDA	+73 days
2 Aug 2023	Published in enforcement report	+12 days

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

Reason for recall

If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported

Product as listed by the FDA

QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

Where it was distributed

AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA

Alabama Arkansas California District of Columbia Florida Georgia Idaho Kansas Kentucky Maryland Minnesota New Jersey New York Pennsylvania South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 14053228038846 LOT Number: 175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783

Where was it sold?

AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA

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

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	Potency & Assay	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 -US IVD qualitative recalled	Qiagen	Other	14 states
8 Aug 2018Device	CLASS II	EZ1 DSP Virus Kit , IVD recalled by QIAGEN	Qiagen	Other	DE, MD
27 Dec 2017Device	CLASS II	QIAamp DSP Virus Kit recalled by Qiagen	Qiagen	Other	AR, DE, IN

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Reported	Class	Recall	Company	Reason	Where
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	Device Malfunction	Nationwide