Siemens Healthcare Diagnostics, Inc. ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Recommended Action

Per FDA guidance

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. Open the Sample Identification screen to determine if the checkbox to turn the Barcode Encoded Selectivity is on o If Barcode Encoding Selectivity is disabled, please perform the following steps to enable Barcode Encoding Selectivity: Open the Sample Identification screen Select the checkbox to turn the Barcode Encoded Selectivity on Whether or not you have the Barcode Encode Selectivity feature disabled, please complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.