Company:Bayer Healthcare, LLC
Date of Enforcement Report:9/6/2006
Class:ll
PRODUCT
ADVIA 2120 systems –Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06
REASON
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.
CODE
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).
RECALLING FIRM/MANUFACTURER
Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, by Support Bulletins on March 16, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
318 units
DISTRIBUTION
Nationwide and Internationally
