Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Detect Covid19 Test

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Detect Covid19 Test see related information
Date Initiated by Firm December 08, 2022
Date Posted January 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-0879-2023
Recall Event ID 91300
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Detect Covid-19 Test
Product/Model Number: 21205
Code Information HY263, HY264, and HB264 Expiration 01JAN2023
Recalling Firm/
Manufacturer		 Detect Headquarters
351 New Whitfield St
Guilford CT 06437-3400
For Additional Information Contact Customer Support
855-322-3692
Manufacturer Reason
for Recall		 There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
FDA Determined
Cause 2		 Component design/selection
Action On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line "URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests". Direct customers were notified on December 12, 2022. Customers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect.
Quantity in Commerce 10142 (US); 960 OUS
Distribution Domestic distribution nationwide. Foreign distribution to Hong Kong.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-