ADVIA 2120 systems -Automated Complete Blood Cell and… recallZ-1376-06 · Bayer Healthcare, LLC (Diagnostics Division) · initiated Mar 16, 2006
Terminated All recalls posted in August 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bayer Healthcare, LLC (Diagnostics Division) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1376-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 16, 2006
- Posted by the FDA
- Aug 4, 2006
- Recalling firm
- Bayer Healthcare, LLC (Diagnostics Division)
- Quantity
- 60 units Domestic, 258 units Foreign
- Product code
- GKL
- FDA submissions
- K971998
- 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 description
ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Code information (models, lots, serial numbers)
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).
Other devices under the same FDA submission
1 device cleared under K971998 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA® 120 Hematology System 10360958Siemens Healthcare Diagnostics Inc. · Counter, differential cell1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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