# FDA recall Z-1291-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-02-20.

## Product

VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below  Product Code: 	6844461     For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

## Reason for recall

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on  VITROS¿ Systems

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

## Key facts

- **Recall number:** Z-1291-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-20
- **Report date:** 2019-05-15
- **Termination date:** 2021-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2019

## Citation

> AI Analytics. FDA recall Z-1291-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1291-2019. Source: US FDA. Licensed CC0.

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