ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Reported: April 29, 2020 Initiated: February 3, 2020 #Z-1761-2020
Product Description
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - 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.
Details
- Recalling Firm
- Radiometer Medical ApS
- Units Affected
- 3,968 units
- 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.
- Location
- Bronshoj, N/A
Frequently Asked Questions
What product was recalled? ▼
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.. Recalled by Radiometer Medical ApS. Units affected: 3,968 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1761-2020.
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