Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HemosIL PT-Fibrinogen HS PLUS Recalled by Instrumentation Laboratory Co. Due to Some vials of HemosIL PT-Fibrinogen HS PLUS, Part...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory Co. directly.
Affected 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).
Quantity: USA: 4088 kits; Foreign: 97,925 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumentation Laboratory Co.
Instrumentation Laboratory Co. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report