CLASS II Device recall · Reported 16 Sep 2020 · FDA Enforcement Report

QIAstat-Dx Respiratory Sars-CoV-2 Panel recalled by Qiagen Sciences

Qiagen Sciences is recalling QIAstat-Dx Respiratory Sars-CoV-2 Panel, distributed nationwide in the US. The recall was initiated on 15 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508

Quantity recalled1474 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-2938-2020
FDA event ID: 86149
Recalling firm: Qiagen Sciences, Germantown, MD
Classification: Class II
Status: Terminated
Recall initiated: 15 Jul 2020
FDA classified: 4 Sep 2020
Reported: 16 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

15 Jul 2020	Recall initiated by company
4 Sep 2020	Classified by FDA	+51 days
16 Sep 2020	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

There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.

Product as listed by the FDA

QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

Where it was distributed

US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.

Nationwide Alaska Alabama California District of Columbia Delaware Florida Georgia Illinois Indiana Kentucky Massachusetts Maryland Minnesota North Carolina New Jersey New York Ohio Oregon Pennsylvania Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508

Where was it sold?

US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.

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
14 Jun 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic recalled	Qiagen Sciences	Other	Nationwide
21 Sep 2022Device	CLASS II	QIAcube Connect MDx recalled by Qiagen Sciences	Qiagen Sciences	Other	26 states

Other CPAP & Ventilators recalls

All 552

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