# FDA recall Z-2467-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2020-05-11.

## Product

ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI:  05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

## Reason for recall

Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number.  Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, 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, SC, SD, TN, TX, UT,  VA, VT, WA, WI, WV, WY and the country of CA.

## Key facts

- **Recall number:** Z-2467-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-11
- **Report date:** 2020-07-08
- **Termination date:** 2023-02-24

- **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-2467-2020

## Citation

> AI Analytics. FDA recall Z-2467-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2467-2020. Source: US FDA. Licensed CC0.

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