Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent
Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Instrumentation Laboratory Co. is recalling specific lots of HemosIL PT-Fibrinogen HS PLUS, an in vitro diagnostic (IVD) reagent used for the quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT). The recall affects 4,088 kits in the United States and 97,925 kits distributed worldwide.
The recall was initiated because some vials of the reagent, specifically those from various lots manufactured prior to June 2014, exhibit a yellow or brownish color after reconstitution instead of the typical white to off-white color. Vials exhibiting this discoloration have been observed to cause prolonged prothrombin (PT) clotting times, which could lead to inaccurate test results.
The affected lots include N1122175, N0132936, N0233302, N0333382, E033382, N0333626, N0433932, N0634953, N0735317, N0735599, N0836106, N0936197, N0349325, N1222324, N0148094, N0248652, N0249017, N0449790, and N0440009. Users should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- 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 Coag
- Manufacturer
- Instrumentation Laboratory Co.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- N0333626
- 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
Distribution
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