Recall Z-2353-2024 · JJH Clinical Sample Concentrator

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

Date	Jul 12, 2024 (initiated Jun 3, 2024)
Status	Open, Classified
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 t
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
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.