Z-1392-2021Class II

ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10...

Name: Z-1392-2021 ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-03-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-03-05 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11 on 2021-03-05. FDA classified it as Class II and gives the reason as "Potential Sample Identification (SID) Mismatch with14-Character Barcodes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1392-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-05
Posted: 2021-04-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Product code: GKZ Counter, Differential Cell
Reason for recall: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Root cause tag: labeling and UDI
FDA 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. 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.
Quantity in commerce: 1 unit
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, 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.
Product codes and lots: Software Versions 6.10 and 6.11 UDI: 00630414237879

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1386-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1387-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1388-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1389-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1390-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1391-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1392-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1393-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1394-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1395-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1396-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1397-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1398-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1399-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1400-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1401-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1402-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1403-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1404-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1405-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code GKZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)