Qiagen recalls QIAcube Connect MDx instruments with heater shaker modules that may not heat below 40°C, causing delayed or erroneous DNA results. Affected units have serial numbers 30000-30506.
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.
Qiagen is recalling QIAcube Connect MD: heater shaker modules may not heat properly below 40°C when using specific DNA extraction kits, which could lead to delayed or incorrect test results. This affects lab equipment used for DNA testing in medical and research settings.
The heater shaker module fails to heat when set below 40°C during certain DNA extraction protocols. This could cause delayed or incorrect results in downstream tests, but does not pose a direct safety risk like fire or injury.
Lab technicians and researchers using QIAcube Connect MDx instruments with serial numbers 30000-30506 for DNA testing. Those using the specific QIAamp DSP DNA Mini Kit protocol are most at risk.
Check if your QIAcube Connect MDx has a serial number between 30000 and 30506. The instrument was sold with software version 1.0.1 and GTIN 04053228039129.
Verify your QIAcube Connect MDx has a serial number between 30000 and 30506.
Ensure you are using the QIAamp DSP DNA Mini Kit (cat. no. 61304) with the specific protocol for Gram-positive bacteria DNA extraction.
The heater shaker module may not heat properly below 40°C during certain DNA extraction protocols, which could cause delayed or incorrect test results.
No, but you should check if your serial number is in the affected range (30000-30506) and follow the protocol instructions carefully.
Check your serial number and ensure you are using the correct protocol for the QIAamp DSP DNA Mini Kit. Later serial numbers and warehouse units will have supplemental instructions for heating below 40°C.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2353-2024 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2353-2024 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
