CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
QIAcube Connect MDx - IVD Instrument designed to perform recalled
Qiagen Sciences is recalling QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and, distributed nationwide in the US. The recall was initiated on 3 Jun 2024 and the FDA has classified it as Class II.
Check your package
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-2353-2024
- FDA event ID
- 94836
- Recalling firm
- Qiagen Sciences, Germantown, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2024
- FDA classified
- 12 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Jun 2024 | Recall initiated by company | |
| 12 Jul 2024 | Classified by FDA | +39 days |
| 24 Jul 2024 | 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
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
Where it was distributed
Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
Nationwide CaliforniaDelawareIdahoIndianaNevadaNew YorkOhioOklahomaOregonPennsylvaniaSouth CarolinaSouth DakotaTennesseeTexasUtahVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Which lots are affected?
GTIN 04053228039129 ALL serial numbers shipped to date. SN 30000-30506 is the impacted range (later serial numbers and units in QIAGEN warehouses will include supplemental instructions for operating the heater in protocols requiring incubation temperatures of 40C or lower prior to shipment)
Where was it sold?
Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
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 |
|---|---|---|---|---|---|
| Device | CLASS II | QIAstat-Dx Respiratory Panel Plus Reference Number recalled | Qiagen Sciences | Device Malfunction | 12 states |
| Device | CLASS II | EZ2 Connect MDx-IVD Designed to perform automated isolation recalled | Qiagen Sciences | Temperature Abuse | Nationwide |
| Device | CLASS II | QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic recalled | Qiagen Sciences | Other | Nationwide |
| Device | CLASS II | QIAcube Connect MDx recalled by Qiagen Sciences | Qiagen Sciences | Other | 26 states |
| Device | CLASS II | therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences | Qiagen Sciences | Other | 4 states |
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