Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Brand
Bayer Healthcare, LLC (Diagnostics Division)
Lot Codes / Batch Numbers
ADVIA 2120 Part No. 067-A012-01 (without Autosampler) and Part No. 067-A011-02 (with Autosampler), 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).
Products Sold
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).
Bayer Healthcare, LLC (Diagnostics Division) is recalling ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter due to The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026