# FDA recall Z-1358-2024

> **Bio-Rad Laboratories** · Class II · device recall initiated 2024-02-15.

## Product

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

## Reason for recall

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

## Distribution

US Nationwide distribution in the states of PA, SD, TX, FL, MN.

## Key facts

- **Recall number:** Z-1358-2024
- **Recalling firm:** Bio-Rad Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-15
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2024

## Citation

> AI Analytics. FDA recall Z-1358-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1358-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*