Z-1376-06

ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

Name: Z-1376-06 ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Creator: Bayer Healthcare, LLC (Diagnostics Division)
Published: 2006-03-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-03-16 / Terminated

FDA source

Bayer Healthcare, LLC (Diagnostics Division) began a recall of ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter on 2006-03-16. The reason FDA records is "The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1376-06
Status: Terminated
Initiated: 2006-03-16
Posted: 2006-08-04
Terminated: 2012-05-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram.
FDA root cause: Other
Action: Bayer HealthCare LLC issued Support Bulletins to all affected Bayer HealthCare LLC Branches on 3/16/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Bayer also issued Customer Bulletins to the Branches both in the United States and elsewhere for communication with the affected customers.
Quantity in commerce: 60 units Domestic, 258 units Foreign
Distribution: Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1), United Arab Emirates (1), South Africa (2), United Kingdom (31), Germany (1), Poland (9), Norway (1), Spain (48), Finland (7), Denmark (4), Portugal (14), Italy (5), Netherlands (3), France (46), Ireland (4), India (7), Austria (1).
Product codes and lots: ADVIA 2120 Part No. 067-A012-01 (without Autosampler) and Part No. 067-A011-02 (with Autosampler); all ADVIA 2120 systems using Version 5 system software including Version 5.0.6 (Part No. 067-S045-06, English version), Version 5.1.1 (Part No. 067-S058-01, English version), and Version 5.2.7 (Part No. 067-S045-15, English version).

Product code GKL

K971998Class IIAdvia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. / cleared 1997-08-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)