Devices

Device Recall CELLDYN 3500 Hematology Analyzer

Model / Serial
Model number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, all serial numbers distributed before May 3, 2007. Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03, all serial numbers distributed on or before May 3, 2007: 91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.
Product Description
Abbott CELL-DYN 3500 Hematology Analyzer
Manufacturer
Abbott Laboratories
1 Event
- Recall of Device Recall CELLDYN 3500 Hematology Analyzer

Manufacturer

Abbott Laboratories

Manufacturer Address
Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
Source
USFDA

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