# FDA recall Z-2623-2023

> **Ortho-Clinical Diagnostics, INc.** · Class II · device recall initiated 2023-08-05.

## Product

VITROS XT Chemistry Products TBIL-ALKP Slides

## Reason for recall

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

## Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom

## Key facts

- **Recall number:** Z-2623-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, INc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-05
- **Report date:** 2023-09-27

- **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-2623-2023

## Citation

> AI Analytics. FDA recall Z-2623-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2623-2023. Source: US FDA. Licensed CC0.

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