# FDA recall Z-0231-2018

> **Radiometer America Inc** · Class II · device recall initiated 2017-10-24.

## Product

ABL800 analyzer with FLEXQ module.    Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter

## Reason for recall

Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

## Distribution

USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY.  Distributed internationally to Canada.

## Key facts

- **Recall number:** Z-0231-2018
- **Recalling firm:** Radiometer America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-24
- **Report date:** 2017-12-20
- **Termination date:** 2023-10-10

- **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-0231-2018

## Citation

> AI Analytics. FDA recall Z-0231-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0231-2018. Source: US FDA. Licensed CC0.

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