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Radiometer Medical ApS recalls ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use
Recalled April 29, 2020 · FDA recall Z-1760-2020 · Radiometer Medical ApS
Hazard
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. · FDA Class II
Units
12,822 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Radiometer Medical ApS
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →