FDA recall Z-2353-2024

Qiagen Sciences LLC · Class II · device

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

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.

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

Key facts

Status
Ongoing
Initiation date
2024-06-03
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2353-2024