# FDA recall Z-3044-2018

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

## Product

VITROS Chemistry Products Cl- Slides, Product Code 684 4471    Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.    Product Usage:

## 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-3044-2018
- **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-3044-2018

## Citation

> AI Analytics. FDA recall Z-3044-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3044-2018. Source: US FDA. Licensed CC0.

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