Z-2353-2024Class II

QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic...

Name: Z-2353-2024 QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic...
Creator: Qiagen Sciences LLC
Published: 2024-06-03
License: https://open.fda.gov/license/

Qiagen / initiated 2024-06-03 / Open, Classified / root cause: software

FDA source

Qiagen Sciences LLC began a recall of QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology... on 2024-06-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2353-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-07-12
Recalling firm: Qiagen
Product: 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
Product code: JJH Clinical Sample Concentrator
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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,
Quantity in commerce: 419 units
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 codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2353-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2353-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)