Qiagen Sciences LLC: Device Recall

Recall #Z-2353-2024 · 06/03/2024

Class II: Risk

Recall Details

Recall Number: Z-2353-2024
Classification: Class II
Product Type: Device
Recalling Firm: Qiagen Sciences LLC
Status: Ongoing
Date Initiated: 06/03/2024
Location: Germantown, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 419 units

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.

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

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

Other Recalls by Qiagen Sciences LLC

Class II: Risk 03/12/2025

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

View all recalls by Qiagen Sciences LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.