Z-2320-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 10, 2019
- Termination Date
- June 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,042 units
Product Description
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Reason for Recall
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Distribution Pattern
US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
Code Information
All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX