FDAClass IIOctober 11, 2017

Human Alpha-1-Antitrypsin Kit for use on the SPAPlus recall

Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd.…

Why was Human Alpha-1-Antitrypsin Kit for use on the SPAPlus recalled?

The high control for the kit is recovering low and may be out of range for assigned values.

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 #400900, Exp. 12/31/2017, UDI #05051700016421

Product
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd.…
Recalling firm
The Binding Site Group, Ltd.
Quantity
361 kits
Distribution
Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
Recall date
October 11, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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