# FDA recall Z-1508-2024

> **Qiagen Sciences LLC** · Class II · device recall initiated 2024-03-04.

## Product

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications.  Model Number: 9003230

## Reason for recall

Insufficient welding leads to the heater cable becoming brittle and  present with an error:  ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost

## Distribution

Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH

## Key facts

- **Recall number:** Z-1508-2024
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-04
- **Report date:** 2024-04-17

- **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-1508-2024

## Citation

> AI Analytics. FDA recall Z-1508-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1508-2024. Source: US FDA. Licensed CC0.

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