Qiagen Sciences LLC: Medical Device Recall in 2024 - (Recall #: Z-2353-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 3, 2024

Date Posted: July 24, 2024

Recall Number: Z-2353-2024

Event ID: 94836

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.

Status: Ongoing

Product Quantity: 419 units

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated