Chembio Diagnostics, Inc Chembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

FDA revocation of the Emergency Use Authorization due to performance issues

Recommended Action

Per FDA guidance

Chembio Diagnostic Systems issued written notification letter to each affected customer and distributor via e-mail on June 18, 2020. Letter states reason for recall, health risk and action to take:Chembio requested that the customers cease use of the product and return unused product to Chembio for a credit to your account. All customers were instructed to complete a returned goods authorization form and return to Chembio indicating the customer has received the notification and complied with the instructions. Chembio then contacted the customer and issued a Returned Goods Authorization number (RGA #) and further instructions for returning any unused DPP COVID-19 IgM/IgG System test devices and the DPP Micro Reader and/or DPP Micro Reader II to Chembio. Distributors were instructed to notify all consignees of this notification advising them of the situation and to cease use of the product and instruct them to return unused product. Customers will be issued credit or replacement as soon as possible upon return of any remaining unused product