synchron

M310400

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide & Canada

SYNCHRON Clinical Systems Enzyme Validator Kit

Multiple lots are involved.    |SYNCRHON: | | |  |Lot 446 ¿ Manufactured 20 NOV 2004* |231 |N/A** |  |Lot 450 ¿ Manufactured 12 DEC 2004 |880 | |  |Lot 501 ¿ Manufactured 03 JAN 2005 |30 | |  |Lot 504 ¿ Manufactured 24 JAN 2005 |698 | |  |Lot 507 ¿ Manufactured 21 FEB 2005 |400 | |  |Lot 508 ¿ Manufactured 28 FEB 2005 |130 | |  |Lot 512 ¿ Manufactured 28 MAR 2005 |1643 | |  |Lot 517 ¿ Manufactured 02 MAY 2005 |2020 | |  | | | |  |EL-ISE: | | |  |Lot 0446 ¿ Manufactured 20 NOV 2004* |20 |N/A** |  |Lot 0504 ¿ Manufactured 24 JAN 2005 |30 | |  |Lot 0508 ¿ Manufactured 28 FEB 2005 |30 | |  |---------------------------------------------+---------------+---------------------|

Clinical Chemistry and Clinical Toxicology Devices

2

No

United States and Canada

Potassium Electrode Tip; || Part No.s: || 668281 Tip Assembly- Synchron Family || 669117 Packaged- Synchron Family || 441104 Electrode Assembly- EL-ISE || 445604 Electrode Packaged- EL-ISE

Operating Software Version 4.5

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide, also Canada, France, Germany, Switzerland, UK, Spain, Belgium, Italy, Netherlands, Sweden, Czech Republic and other countries within Europoe, So. Africa, Isreal Kuwait, united Arab Emirates, Mexico, Argentina, Japan, Australia, Hong Kong, China, Taiwan, Korea, Asia, Africa and the Middle East. Note: According to the firm Customer lists for countires outside North America are maintained by regional offices. If necessary, requests can be made to gather the complete lists.

SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part Number: A23724 In vitro diagnostic.

Software Version 4.5

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide, also Canada, France, Germany, Switzerland, UK, Spain, Belgium, Italy, Netherlands, Sweden, Czech Republic and other countries within Europoe, So. Africa, Isreal Kuwait, united Arab Emirates, Mexico, Argentina, Japan, Australia, Hong Kong, China, Taiwan, Korea, Asia, Africa and the Middle East. Note: According to the firm Customer lists for countires outside North America are maintained by regional offices. If necessary, requests can be made to gather the complete lists.

SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724

Software Version 1.0 and 1.2

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide, also Canada, France, Germany, Switzerland, UK, Spain, Belgium, Italy, Netherlands, Sweden, Czech Republic and other countries within Europoe, So. Africa, Isreal Kuwait, united Arab Emirates, Mexico, Argentina, Japan, Australia, Hong Kong, China, Taiwan, Korea, Asia, Africa and the Middle East. Note: According to the firm Customer lists for countires outside North America are maintained by regional offices. If necessary, requests can be made to gather the complete lists.

Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331