CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report

QIAcube Connect MDx recalled by Qiagen Sciences

Qiagen Sciences is recalling QIAcube Connect MDx, distributed nationwide in the US. The recall was initiated on 21 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076

Quantity recalled93 US; 57 OUS

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-1746-2022
FDA event ID: 90758
Recalling firm: Qiagen Sciences, Germantown, MD
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2021
FDA classified: 15 Sep 2022
Reported: 21 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

21 Nov 2021	Recall initiated by company
15 Sep 2022	Classified by FDA	+298 days
21 Sep 2022	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

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

QIAcube Connect MDx, Model No. 9003070

Where it was distributed

Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.

Nationwide Arizona California Colorado District of Columbia Delaware Florida Georgia Iowa Kansas Louisiana Massachusetts Maryland Minnesota North Carolina New Jersey Nevada New York Ohio Pennsylvania South Carolina

Questions about this recall

Is QIAcube Connect MDx recalled?

Yes. Qiagen Sciences recalled QIAcube Connect MDx on 21 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-1746-2022.

Why was it recalled?

Which lots are affected?

UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076

Where was it sold?

Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.

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.

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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
7 Sep 2022Device	CLASS II	therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	4 states

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