# FDA recall Z-1684-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2020-03-10.

## Product

ABL800 FLEX, model number/UDI 393-800/0570  In Vitro testing of samples of whole blood for the parameters pH, pO2, 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   In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:

## Reason for recall

Analyzer's barcode reader misinterprets the contents of barcode  label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of Canada, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Croatia, Russia, Norway.

## Key facts

- **Recall number:** Z-1684-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-10
- **Report date:** 2020-04-15
- **Termination date:** 2022-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2020

## Citation

> AI Analytics. FDA recall Z-1684-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1684-2020. Source: US FDA. Licensed CC0.

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