Z-2494-2020 Class II Terminated
FDA device recall Z-2494-2020 was initiated by Radiometer Medical ApS on May 26, 2020 and is designated Class II. Reason for recall: Potential risk of patient mix-up on analyzers due to software issues. The recall status is terminated (terminated February 8, 2023). Affected quantity: 3,899 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 26, 2020
- Termination Date
- February 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,899 units
Product Description
Reason for Recall
Distribution Pattern
US - AL, AR, AZ, BM, 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, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom