# FDA recall Z-2353-2024

> **Qiagen Sciences LLC** · Class II · device recall initiated 2024-06-03.

## 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

- **Recall number:** Z-2353-2024
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-03
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2353-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2353-2024. Source: US FDA. Licensed CC0.

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