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
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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
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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 |
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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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