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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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36 records meeting your search criteria returned- Product Code: NIG Product Problem: Incorrect Or Inadequate Test Results Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY 06/26/2018
ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE 03/29/2018
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 03/15/2018
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 01/23/2018
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 12/29/2017
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 12/12/2017
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 11/29/2017
ABBOTT LABORATORIES ARCHITECT CA19-9XR REAGENTS 11/16/2017
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 11/03/2017
ABBOTT LABORATORIES ARCHITECT CA 19-9XR 10/26/2017
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