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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1726926
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2022
Event Type  malfunction  
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Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Type of DeviceIN-VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
513 technology blvd.
rochester NY 14652
Manufacturer Contact
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key14318128
Report Number1319809-2022-00025
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Reporter Country CodeRP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1726926
Device Lot Number1018-0256-9803
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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