FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: 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
- Recall number
- Z-2353-2024
- Recalling firm
- Qiagen Sciences LLC
- 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
- Status
- Open, Classified
- Initiated
- 2024-06-03
- Posted
- 2024-07-12
- Terminated
- not on file
- Reason
- 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
- 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 quality.communications@qiagen.com 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
- 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
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJH
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28