LLC, Class II Bayer Healthcare

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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

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Location: Boston, MA, USA
Dates:  June 2-4, 2020

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.