Recall Z-1401-2021

Siemens Healthcare Diagnostics, Inc. · initiated March 5, 2021

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

Codes / lots: Software Versions 6.10 and 6.11

Reason for recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDA-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-1401-2021
Initiated
March 5, 2021
Product code
GKZ – Counter, Differential Cell
Quantity
1452 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 Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany…
Recalling firm
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1386-2021 Class IIADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1387-2021 Class IIADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1388-2021 Class IIADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1389-2021 Class IIADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1390-2021 Class IIADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1391-2021 Class IIADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1392-2021 Class IIADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1393-2021 Class IIADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1394-2021 Class IIADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1395-2021 Class IIADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1396-2021 Class IIADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1397-2021 Class IIADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1398-2021 Class IIADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1399-2021 Class IIADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1400-2021 Class IIADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1402-2021 Class IIADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1403-2021 Class IIADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1404-2021 Class IIADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified
Z-1405-2021 Class IIADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes 03/05/2021Open, Classified