Z-0816-2014 Class II Terminated
FDA device recall Z-0816-2014 was initiated by Radiometer America Inc on October 15, 2013 and is designated Class II. Reason for recall: RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. The recall status is terminated (terminated June 19, 2014). Affected quantity: Total 3414 (US 524, CA 31, ROW 2859).
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2014
- Initiation Date
- October 15, 2013
- Termination Date
- June 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 3414 (US 524, CA 31, ROW 2859)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.