# FDA recall Z-0844-2021

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2020-12-15.

## Product

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems   Product Code: 8392292

## Reason for recall

Eltrombopag Interference  for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.

## Key facts

- **Recall number:** Z-0844-2021
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-15
- **Report date:** 2021-01-20
- **Termination date:** 2021-07-27

- **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-0844-2021

## Citation

> AI Analytics. FDA recall Z-0844-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0844-2021. Source: US FDA. Licensed CC0.

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