Instrumentation Laboratory Co. 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). Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch 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.
Products Sold
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.
Instrumentation Laboratory Co. is recalling HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity due to Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 15, 2026