FDAClass IIAugust 26, 2020

Chembio DPP COVID-19 IgM/IgG System- Rrapid recall

Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and…

Why was Chembio DPP COVID-19 IgM/IgG System- Rrapid recalled?

FDA revocation of the Emergency Use Authorization due to performance issues

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 Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120

Product
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and…
Recalling firm
Chembio Diagnostics, Inc
Quantity
7,674 kits (153,480 devices)
Distribution
Nationwide
Recall date
August 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls