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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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6 records meeting your search criteria returned- Product Code: JIX Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS AMMONIA/ETHANOL/CO2 CA 06/21/2022
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CHEMISTRY CALIBRATOR (CHEM C 04/28/2022
ROCHE DIAGNOSTICS LI 12/30/2021
ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 07/02/2020
ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 05/30/2018
ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 01/05/2018
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