Recall Z-1405-2021 · GKZ Counter, Differential Cell
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
| Date | Mar 5, 2021 |
| Status | Open, Classified |
| Reason | Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter HSW21-01.A.US to US customers on March 5, 2021 via FedEx overnight delivery. An Urgent Field Safety Notice (UFSN) HSW21-01.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: with your Medical Director. If you are using 14-character Sample Identification (SID) barcodes: o Ensure that the Barcode Encoding Selectivity feature is enabled. Op |
| Quantity | 674 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |