FDAClass IIApril 5, 2023

MicroVue C1-Inhibitor Plus EIA for measuring the amount recall

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing…

Why was MicroVue C1-Inhibitor Plus EIA for measuring the amount recalled?

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI: 30014613335580; Lot Number: 213783

Product
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing…
Recalling firm
Quidel Corporation
Quantity
771 units
Distribution
not yet available
Recall date
April 5, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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