# FDA recall Z-0740-2020

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2019-10-14.

## Product

Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

## Reason for recall

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

## Distribution

Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT,  PL, RU, DK, NO, SE, BE, NL.

## Key facts

- **Recall number:** Z-0740-2020
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-14
- **Report date:** 2020-01-01
- **Termination date:** 2020-11-13

- **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-0740-2020

## Citation

> AI Analytics. FDA recall Z-0740-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0740-2020. Source: US FDA. Licensed CC0.

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