Atellica Sample Handler Prime, Material Number 11069001
- Recall Initiated
- March 7, 2019
- Terminated
- August 20, 2020
- Recall Number
- Z-1301-2019
- Quantity
- 474
- Firm Location
- Tarrytown, NY
Reason for Recall
There were multiple issues identified in the system software which required an update.
Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
Lot / Code Info
UDI: 00630414002026
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.