# FDA recall Z-1556-2023

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2023-03-10.

## Product

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products   MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products  Reagents  Product Code:  6802413

## Reason for recall

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

## Distribution

Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada   Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom

## Key facts

- **Recall number:** Z-1556-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2023

## Citation

> AI Analytics. FDA recall Z-1556-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1556-2023. Source: US FDA. Licensed CC0.

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