QIAcube Connect MDx - IVD Instrument designed to perform… recallZ-2353-2024 · Qiagen Sciences LLC · initiated Jun 3, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Qiagen Sciences LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Heater shaker module does not perform heating if the temperature is set below 40C 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.

FDA root cause category: Software design

What the company is doing

Qiagen issued Urgent Medical Device Correction Letter to Lab Director/Manager, Medical Director, Risk Manager, Safety Officer via email on June 3, 2024. Letter states reason for recall, health risk and action to take: l Complete the Acknowledgment of Receipt promptly and return to [email protected] l If running the above protocols and you have selected an incubation temperature for the bacterial lysis below 40C, then you can ensure precise temperature control by using the heater shaker built into the QIAcube Connect MDx via the Tools menu of the software. If you wish to check the actual applied temperature in your workflow as currently used, we offer to analyze your logfiles to determine the actual applied temperature. This may help you to confirm these settings. Please contact QIAGEN Technical Services at (800 362 7737) for assistance,

Recall details

Recall number: Z-2353-2024
Status: Open, Classified
Initiated by the company: Jun 3, 2024
Posted by the FDA: Jul 12, 2024
Recalling firm: Qiagen Sciences LLC
Quantity: 419 units
Product code: JJH
Distribution: 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

Product description

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

Code information (models, lots, serial numbers)

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)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

QIAcube Connect MDx 1
QIAGEN GmbH · Clinical Sample Concentrator
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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