# FDA recall Z-3184-2018

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

## Product

VITROS Chemistry Products Cl- Slides, Product Code 684 4471    Product Usage:  VITROS Cl Slides (Product Code 684 4471) - 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.

## Reason for recall

The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl-  slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.

## Distribution

Worldwide Distribution - US Nationwide- The products were distributed to the following foreign countries: 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-3184-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-11
- **Report date:** 2018-09-26
- **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-3184-2018

## Citation

> AI Analytics. FDA recall Z-3184-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3184-2018. Source: US FDA. Licensed CC0.

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