Product Description
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).
Reason for Recall
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.
Action Details
The firm, Instrumentation Laboratory, sent an "URGENT MEDICAL DEVICE CORRECTION" letter (dated 11/21/2014) to US and Canadian customers via USPS on 11/21/2014 for all in-date lots of HemosiL PT-Fibrinogen HS PLUS, Part No. 0008469810, manufactured prior to June 2014. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: if they observe any yellow/brownish color after reconstitution, they are not to use the affected vial; discard the vial and reconstitute another vial; only use a vial if the reconstituted color is the typical white to off-white color; run quality controls at least once every 8 hour shift in accordance with GLP and insert instruction sheet; share this information with your laboratory staff and follow initial procedures; forward this notification to all affected locations within your facility; retain a copy of this notification for your records and complete and return the tracking record form within 10 business days of receiving notification even if you do not use these reagents via fax at 781-861-4207 or email to: ra-usa@ilww.com.
On 11/21/2014, e-mail notifications were sent to the IL/Werfen Country Affiliates and International Group (who manage the local country dealers and distributors) to prepare and issue Field Safety Notices in the respective languages to their customers.
For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For additional questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 2.
Distribution Pattern
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.
Code Information / Serial Numbers
Lots: N1122175, exp. date 11/30/2014; N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015; N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015; N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016; N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.