Z-1760-2020 Class II Terminated
FDA device recall Z-1760-2020 was initiated by Radiometer Medical ApS on February 3, 2020 and is designated Class II. 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 … The recall status is terminated (terminated September 20, 2022). Affected quantity: 12,822 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- February 3, 2020
- Termination Date
- September 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,822 units
Product Description
Reason for Recall
Distribution Pattern
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.