FDAClass IIOctober 17, 2018

Hemosll ReadiPlasTin recall

Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent…

Why was Hemosll ReadiPlasTin recalled?

There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number - N0278177 Exp. Date February 28, 2019

Product
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent…
Recalling firm
Instrumentation Laboratory Co.
Quantity
9751 kits
Distribution
US Nationwide
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls