QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu

FDA device recall Z-2353-2024 · posted 2024-07-12 · Open, Classified

Recall details

Recalling firm

Qiagen Sciences LLC

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.

Action taken

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,

Root cause

Software design

Status

Open, Classified

Product code

JJH

Quantity affected

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, U

Date initiated

2024-06-03

Date posted

2024-07-12

Location

Germantown, MD