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Device Recall UniCel Dxl Access Immunoassay System
Model / Serial
221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F (exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp 6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07), 221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F (exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp 6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07), 221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All software versions
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution --- including USA and country of Canada.
Product Description
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
Manufacturer
Beckman Coulter Inc
1 Event
Recall of Device Recall UniCel Dxl Access Immunoassay System
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Manufacturer
Beckman Coulter Inc
Manufacturer Address
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
Source
USFDA
One device with a similar name
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Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels
Model / Serial
Part Number: 386167; Lot Code: 1201291 & 1201431
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide & Canada
Product Description
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
Manufacturer
Beckman Coulter Inc
Language
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