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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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218 records meeting your search criteria returned- Product Code: JJE Product Problem: Device Displays Incorrect Message Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS 10/14/2021
ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM 02/25/2021
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SOLUTION 03/17/2020
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SOLUTION 03/13/2020
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 03/06/2020
ABBOTT LABORATORIES ARCHITECT PLUS C4000 11/26/2019
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 MODULE 11/05/2019
BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER 05/10/2018
ABBOTT MANUFACTURING INC ARCHITECT C4000 CUVETTE SEGMENT 12/01/2017
ABBOTT MANUFACTURING INC ARCHITECT C4000 CUVETTE SEGMENT 11/30/2017
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