# FDA recall Z-1226-2020

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2019-12-16.

## Product

VITROS Chemistry Products Calibrator Kit 2- IVD  calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG  Product Code: 1662659

## Reason for recall

Potential for Negatively Biased Na+ Urine Results Using  Several Lots of VITROS Chemistry Products Calibrator Kit 2

## Distribution

Nationwide  Foreign:  Australia  Brazil  Canada L3R 4G5   Chile  China  Colombia  India  Japan  Mexico  Singapore   United Kingdom  France  Germany  Italy  Spain  Portugal  Poland  Russia  Denmark  Norway  Sweden  Belgium  Netherlands

## Key facts

- **Recall number:** Z-1226-2020
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-02-19
- **Termination date:** 2020-11-12

- **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-1226-2020

## Citation

> AI Analytics. FDA recall Z-1226-2020. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1226-2020. Source: US FDA. Licensed CC0.

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