QIAcube Connect MDx — Class II medical device recall Z-2353-2024
Ongoing recall by Qiagen Sciences LLC, reported 2024-07-24, distributed nationwide. Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps
| Recall number | Z-2353-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2024-06-03 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 419 units |
| Reason classes | microbial contamination, potency |
| UPC / GTIN / UDI-DI | 04053228039129 |
| Model numbers | 900370 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2353-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.