Instrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent
Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential imprecision and out-of-range controls without reporting specific patient injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Instrumentation Laboratory Co. is recalling 9,751 kits of HemosIL ReadiPlasTin (10 mL Size), Part Number 0020301300. The product is an in vitro diagnostic thromboplastin reagent used for the quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma. It is intended for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
The recall is due to a potential for increased imprecision, out-of-range quality controls, and prolonged sample results. The affected lot number is N0278177 with an expiration date of February 28, 2019. The product was distributed nationwide in the United States.
Healthcare facilities and laboratories should stop using the affected product and contact Instrumentation Laboratory Co. for further instructions.
The recalled product
- Product
- Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) an
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 9,751
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 (2)
- Lot Number - N0278177 Exp. Date February 28
- 2019
Distribution
Distributed nationwide across the United States.
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