FDAClass IIAugust 29, 2018

Immunoscan CCPlus test kit is an enzyme-linked recall

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to…

Why was Immunoscan CCPlus test kit is an enzyme-linked recalled?

Decreasing performance overtime.

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 # RS 3092, SS 1737

Product
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to…
Recalling firm
Euro Diagnostica AB
Quantity
25 kits (US only)
Distribution
Minnesota and Texas Foreign: Iran
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls