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Devices
UniCel Dxl 800 Access lmmunoassay System
Model / Serial
Part Number 973100; Serial Numbers: 600469, 601097, 601098, 601144, 601182, 601160, 601188, 601071, 601117, 601114, 601137, 601059, 601039, 601099, 601088, 601176, 601184, 601178, 601025, 601186, 601110, 601063, 601002, 601029, 601133, 601106, 601215, 601159, 601077, 601202, 601206, 601079, 601051, 601179, 601130, 601058, 601031, 601212, 601173, 601028, 601078, 601094, 601210, 601189, 601228, 601043, 601092, 601171, 601026, 601122, 601208, 601103, 601089, 601108, 601183, 600933 600971, 600919, 600910, 600904, 600935, 601005, 600977, 600936, 600993, 600965, 601011, 600957, 600918, 601015, 600992, 600905, 600914, 600947, 601016, 601013, 600981, 600903, 600949, 601012, 600983, 600970, 600912, 601004, 600915, 600907, 600987, 600939, 600996, 601007, 600899, 601006, 600938, 600952, 600988, 601020, 600928, 600937, 600972, 955056, 965059, 954609, 949471, 954490, 501442, and 499300.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Beckman Coulter UniCel Dxl 800 Access Immunoassay System; || Part Number: 973100 || With: UniCel Dxl 800 Modification (MOD ID 10027) || and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.
Manufacturer
Beckman Coulter Inc
1 Event
Recall of UniCel Dxl 800 Access lmmunoassay System
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Manufacturer
Beckman Coulter Inc
Manufacturer Address
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
Source
USFDA
Language
English
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