Class II — Qiagen Sciences LLC
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 |
| Quantity | 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, UT, VA, WA, WI |
| Initiated | 2024-06-03 |
| Classified | 2024-07-12 |
| Recall number | Z-2353-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qiagen Sciences LLC (Z-2353-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94836/
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