Devices

Device Recall CellDyn 3500 System with Immature Reticulocyte Fraction (IRF)

Model / Serial
List Number 91350-01; lot numbers: 31222P, 32091P Refurbished list number: 91350-03; lot number: 32159P96
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
Product Description
CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). || Abbott Diagnostics Division, Santa Clara, CA 05054 || Designed for in vitro diagnostic use in clinical laboratories.
Manufacturer
Abbott Laboratories
1 Event
- Recall of Device Recall CellDyn 3500 System with Immature Reticulocyte Fraction (IRF)

Manufacturer

Abbott Laboratories

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

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