FDAClass IIMarch 14, 2018

Hemosll ReadiPlasTin recall

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Why was Hemosll ReadiPlasTin recalled?

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including 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?

Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.

Product
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Recalling firm
Instrumentation Laboratory Co.
Quantity
14,894 kits
Distribution
Worldwide Distribution - US Nationwide
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls