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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
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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
SENDX MEDICAL, INC. ABL80 FLEX CO-OX ANALYZER 01/16/2015
ROCHE DIAGNOSTICS COBAS B 123 SENSOR CART. BG/ISE/GLU/LAC 12/22/2014
SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 12/16/2014
ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM 11/17/2014
ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM 11/17/2014
RADIOMETER MEDICAL APS ABL90 FLEX 11/15/2014
RADIOMETER MEDICAL APS MEMBRANE BOX FOR CREA A AND CREA B 11/07/2014
RADIOMETER MEDICAL APS MEMBRANE BOX FOR CREA A AND CREA B 11/07/2014
RADIOMETER MEDICAL APS MEMBRANE BOX FOR CREA A AND CREA B 11/07/2014
ROCHE DIAGNOSTICS COBAS B 23 FLUID PACK 11/03/2014
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