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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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84 records meeting your search criteria returned- Product Code: GKZ Product Problem: High Test Results Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM 09/17/2022
SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM 06/17/2022
SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM 06/17/2022
ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM 06/10/2022
ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM 03/25/2022
ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM 01/31/2022
ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM 01/18/2022
ABBOTT LABORATORIES CELL-DYN EMERALD 22 SYSTEM 12/14/2021
ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM 11/22/2021
ABBOTT LABORATORIES CELL-DYN EMERALD 22 AL, INSTRUMENT 10/06/2021
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