# FDA recall Z-1189-2024

> **Abbott Molecular, Inc.** · Class III · device recall initiated 2024-02-01.

## Product

In-vitro diagnostic kits:    (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020;  (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020;  (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001;  (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004;  (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

## Reason for recall

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

## Distribution

US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

## Key facts

- **Recall number:** Z-1189-2024
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-01
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Des Plaines, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2024

## Citation

> AI Analytics. FDA recall Z-1189-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1189-2024. Source: US FDA. Licensed CC0.

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