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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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123 records meeting your search criteria returned- Product Code: CHL Product Problem: Incorrect Or Inadequate Test Results Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 08/08/2016
ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM 07/22/2016
SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 07/13/2016
SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1260 09/24/2015
ROCHE DIAGNOSTICS COBAS B 123 SYSTEM 05/29/2015
ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM 05/29/2015
ROCHE DIAGNOSTICS COBAS B 123 SYSTEM 05/29/2015
ROCHE DIAGNOSTICS OMNI 05/21/2015
ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE 04/27/2015
ROCHE DIAGNOSTICS COBAS B 123 FLUID PACK 01/26/2015
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