Reported Oct 17, 2018 · Terminated
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro…
Instrumentation Laboratory Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory Co. · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- 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) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
- Lot codes and dates
Lot Number - N0278177 Exp. Date February 282019
- Amount recalled
- 9751 kits
Where it was sold
- Nationwide
Why it was recalled
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
This product could cause temporary or reversible health problems — stop using it.
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