FDA-Device2016-06-01Class II
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Hazard
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Sold states
U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
Affected count
135 boxes
Manufactured in
6260 Sequence Dr, N/A, San Diego, CA, United States
Products
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1720-2016Don't want to check this manually?
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