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U.S. Department of Health and Human Services

Class 2 Device Recall Detect Covid19 Test

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 Class 2 Device Recall Detect Covid19 Testsee related information
Date Initiated by FirmDecember 08, 2022
Date PostedJanuary 04, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0879-2023
Recall Event ID 91300
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductDetect Covid-19 Test Product/Model Number: 21205
Code Information HY263, HY264, and HB264 Expiration 01JAN2023
FEI Number 3018103650
Recalling Firm/
Manufacturer		 Detect Headquarters
351 New Whitfield St
Guilford CT 06437-3400
For Additional Information ContactCustomer 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
ActionOn 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 Commerce10142 (US); 960 OUS
DistributionDomestic distribution nationwide. Foreign distribution to Hong Kong.
Total Product Life CycleTPLC 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.
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