FDAClass IIAugust 26, 2020

Chembio DPP¿ Micro Reader for use with the DPP¿ recall

Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and…

Why was Chembio DPP¿ Micro Reader for use with the DPP¿ 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: 83716171 83720151 83720153

Product
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and…
Recalling firm
Chembio Diagnostics, Inc
Quantity
126 kits
Distribution
Nationwide
Recall date
August 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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