Advia

Part No. 073-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide including USA and Puerto Rico.

ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

Part No. 094-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide including USA and Puerto Rico.

ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide including USA and Puerto Rico.

Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

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).

Hematology and Pathology Devices

2

No

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).

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

All lots.

Hematology and Pathology Devices

2

No

Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.-

Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.