Device product
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Z-1386-2021
Product summary
- Event
- Event 87488
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1386-2021
Official wording
Reason: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Code information: Software Versions 6.10 and 6.11 UDI: 00630414501208
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali Malta, Martinique, Mexico, Namibia, Netherlands, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.
Derived failure modes
-
Unknown
Potential Sample Identification (SID) Mismatch with14-Character Barcodes