Z-2807-2020Class II

Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and...

Name: Z-2807-2020 Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and...
Creator: Chembio Diagnostics, Inc
Published: 2020-06-18
License: https://open.fda.gov/license/

Chembio Diagnostic Systems, Inc. / initiated 2020-06-18 / Terminated / root cause: design

FDA source

Chembio Diagnostics, Inc began a recall of Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and... on 2020-06-18. FDA classified it as Class II and gives the reason as "FDA revocation of the Emergency Use Authorization due to performance issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2807-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-08-14
Terminated: 2021-08-11
Recalling firm: Chembio Diagnostic Systems, Inc.
Product: Chembio DPP COVID-19 IgM/IgG System- Rrapid 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: 65-9569-0
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: FDA revocation of the Emergency Use Authorization due to performance issues
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 7,674 kits (153,480 devices)
Distribution: Nationwide
Product codes and lots: Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2807-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2807-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14
Z-2808-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14
Z-2809-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)