Terminated

ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

FDA Recall Z-1376-06 · Posted 2006-08-04

Recalling FirmBayer Healthcare, LLC (Diagnostics Division)

Recall StatusTerminated

Product CodeGKL

Date Initiated2006-03-16

Date Terminated2012-05-24

Product Quantity60 units Domestic, 258 units Foreign

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMBayer Corp. · 1997-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.