# FDA recall Z-1760-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2020-02-03.

## Product

ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

## Reason for recall

The firm received reports of occurrences where the  barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement.  This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.

## Distribution

Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, 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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Netherlands, China, Croatia, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, South Korea, United Kingdom, Poland, Australia, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

## Key facts

- **Recall number:** Z-1760-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-03
- **Report date:** 2020-04-29
- **Termination date:** 2022-09-20

- **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-1760-2020

## Citation

> AI Analytics. FDA recall Z-1760-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1760-2020. Source: US FDA. Licensed CC0.

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