FDA-Device2014-12-31Class II
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Instrumentation Laboratory Co.
Hazard
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.
Sold states
Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
Affected count
USA: 4088 kits; Foreign: 97,925 kits
Manufactured in
180 Hartwell Road, Bedford, MA, United States
Products
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2015Don't want to check this manually?
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