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Class 2 Device Recall ADVIA 2120 systems |
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Date Initiated by Firm |
March 16, 2006 |
Date Posted |
August 04, 2006 |
Recall Status1 |
Terminated 3 on May 24, 2012 |
Recall Number |
Z-1376-06 |
Recall Event ID |
35893 |
510(K)Number |
K971998
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Product Classification |
Blood Cell and Differential Cell Counter - Product Code GKL
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Product |
ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter |
Code Information |
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) 511 Benedict Avenue Tarrytown NY 10591-5097
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For Additional Information Contact |
Mr. Steven Andberg 508-660-8540
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Manufacturer 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.
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FDA Determined Cause 2 |
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). |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GKL and Original Applicant = BAYER CORP.
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