# FDA recall Z-3043-2018

> **Ortho-Clinical Diagnostics** · Class III · device recall initiated 2018-07-11.

## Product

VITROS Chemistry Products Cl- Slides, Product Code 844 5207    Product Usage:  For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

## Reason for recall

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.

## Distribution

Worldwide Distribution - US Nationwide and in the countries of:  Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.

## Key facts

- **Recall number:** Z-3043-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-11
- **Report date:** 2018-09-19
- **Termination date:** 2020-08-11

- **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-3043-2018

## Citation

> AI Analytics. FDA recall Z-3043-2018. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-3043-2018. Source: US FDA. Licensed CC0.

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