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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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63 records meeting your search criteria returned- Product Code: CFR Product Problem: Low Test Results Report Date From: 01/1/2009

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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COBAS C111 09/11/2017
ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE 08/31/2017
ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE 08/31/2017
ROCHE DIAGNOSTICS GLUC3 GLUCOSE HK GEN.3 08/23/2017
ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE 08/16/2017
ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE 08/04/2017
ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE 08/02/2017
ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE 08/01/2017
ORTHO-CLINICAL DIAGNOSTICS VITROS 5,1 FS CHEMISTRY SYSTEM 07/19/2017
ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM 07/06/2017
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