FDAClass IIIAugust 29, 2018

is a quantitative/qualitative enzyme-linked recall

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid…

Why was is a quantitative/qualitative enzyme-linked recalled?

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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 #'s: TS 2819 (kit) and TS 2841 (PC)

Product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid…
Recalling firm
Euro Diagnostica AB
Quantity
6
Distribution
MN
Recall date
August 29, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
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