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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
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14 records meeting your search criteria returned- Product Code: GGN Product Problem: Improper or Incorrect Procedure or Method Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ACCRIVA DIAGNOSTICS DIRECTCHECK ACT-LR QUALITY CONTROL, ABNO 06/26/2018
ACCRIVA DIAGNOSTICS DIRECTCHECK ACT-LR QUALITY CONTROL, NORM 05/11/2018
ACCRIVA DIAGNOSTICS DIRECTCHECK ACT+ ABNORMAL 11/02/2017
ACCRIVA DIAGNOSTICS DIRECTCHECK CITRATE PT ABNORMAL 05/03/2017
ACCRIVA DIAGNOSTICS DIRECTCHECK PT QUALITY CONTROL, ABNORMAL 03/16/2017
ACCRIVA DIAGNOSTICS HEMOCHRON DIRECTCHECK ACT-LR QUALITY CON 03/16/2017
ACCRIVA DIAGNOSTICS HEMOCHRON DIRECTCHECK NORMAL ACT-LR 01/12/2017
ACCRIVA DIAGNOSTICS HEMOCHRON DIRECTCHECK ACT-LR ABNORMAL 01/11/2017
ACCRIVA DIAGNOSTICS HEMOCHRON JR. DIRECTCHECK CITRATE PT ABN 12/02/2016
ACCRIVA DIAGNOSTICS DIRECTCHECK ACT-LR ABNORMAL QUALITY CONT 11/23/2016
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