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U.S. Department of Health and Human Services

Class 2 Device Recall Chembio DPP COVID19 IgM/IgG System

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  Class 2 Device Recall Chembio DPP COVID19 IgM/IgG System see related information
Date Initiated by Firm June 18, 2020
Create Date August 14, 2020
Recall Status1 Terminated 3 on August 11, 2021
Recall Number Z-2807-2020
Recall Event ID 86098
Product Classification Reagent, coronavirus serological - Product Code QKO
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
Code Information Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120
Recalling Firm/
Manufacturer		 Chembio Diagnostics, Inc
3661 Horseblock Rd
Medford NY 11763-2215
For Additional Information Contact Sandy Speer
631-924-1135 Ext. 105
Manufacturer Reason
for Recall		 FDA revocation of the Emergency Use Authorization due to performance issues
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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