# FDA recall Z-3237-2017

> **Radiometer America Inc** · Class II · device recall initiated 2017-09-07.

## Product

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers  The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

## Reason for recall

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2.  A defective QC ampoule will for:  " pCO2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kPa or 36.9  46.9 mmHg)  " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

## Distribution

Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain  France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.

## Key facts

- **Recall number:** Z-3237-2017
- **Recalling firm:** Radiometer America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-07
- **Report date:** 2017-10-11
- **Termination date:** 2019-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3237-2017

## Citation

> AI Analytics. FDA recall Z-3237-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-3237-2017. Source: US FDA. Licensed CC0.

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