FDA-Device2025-04-09Class II
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Hazard
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Sold states
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Affected count
1,699 units
Manufactured in
8365 Valley Pike, Middletown, VA, United States
Products
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1503-2025Don't want to check this manually?
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