QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu
Summary
The FDA issued a Class II for QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and by Qiagen Sciences LLC. Reason: 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 D.
Details
Source
Device Recall
External ID
Z-2353-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
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
Lot/Code Info: 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)
Quantity Affected: 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-03
Company
Germantown, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Qiagen Sciences LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qiagen Sciences LLC have FDA actions?
Qiagen Sciences LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2353-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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