FDA-Device2020-01-01Class II
STA UNICALIBRATOR (ref. 00675)
Diagnostica Stago, Inc.
Hazard
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Sold states
US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
Affected count
5,498
Manufactured in
5 Century Dr, Parsippany, NJ, United States
Products
STA UNICALIBRATOR (ref. 00675)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0737-2020Don't want to check this manually?
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