CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic recalled

Qiagen Sciences is recalling QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic acid real-time PCR test, distributed nationwide in the US. The recall was initiated on 28 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Quantity recalled347 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-1683-2023
FDA event ID: 92298
Recalling firm: Qiagen Sciences, Germantown, MD
Classification: Class II
Status: Ongoing
Recall initiated: 28 Apr 2023
FDA classified: 2 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

28 Apr 2023	Recall initiated by company
2 Jun 2023	Classified by FDA	+35 days
14 Jun 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

Faulty cartridges in the lot could result in false test results.

Product as listed by the FDA

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Nationwide California Florida Illinois Maryland Mississippi New York Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Faulty cartridges in the lot could result in false test results.

Which lots are affected?

GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

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 Sciences

All 23

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025Device	CLASS II	QIAstat-Dx Respiratory Panel Plus Reference Number recalled	Qiagen Sciences	Device Malfunction	12 states
24 Jul 2024Device	CLASS II	QIAcube Connect MDx - IVD Instrument designed to perform recalled	Qiagen Sciences	Potency & Assay	Nationwide
17 Apr 2024Device	CLASS II	EZ2 Connect MDx-IVD Designed to perform automated isolation recalled	Qiagen Sciences	Temperature Abuse	Nationwide
21 Sep 2022Device	CLASS II	QIAcube Connect MDx recalled by Qiagen Sciences	Qiagen Sciences	Other	26 states
7 Sep 2022Device	CLASS II	therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences	Qiagen Sciences	Other	4 states

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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