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U.S. Department of Health and Human Services

Class 2 Device Recall QuickVue Dipstick Strep A Test

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 Class 2 Device Recall QuickVue Dipstick Strep A Testsee related information
Date Initiated by FirmJune 17, 2025
Date PostedSeptember 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2545-2025
Recall Event ID 97271
510(K)NumberK011097 
Product Classification Antigens, all groups, streptococcus spp. - Product Code GTY
ProductQuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Code Information REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)
Recalling Firm/
Manufacturer		 Quidel Corporation
10165 McKellar Ct
San Diego CA 92121-4201
For Additional Information Contact
954-623-9546 Ext. 7922
Manufacturer Reason
for Recall		Dipstick strep A test has potential for false positive results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 6/17/2025, correction notices were mailed to customers who were asked to do the following: 1) Send the enclosed customer letter and Confirmation of Receipt form to customers who were shipped any of the affected lots of Strep A Test from your facility. 2) The response form asks customers to acknowledge they have discontinued distributing and discarded the affected lots of Strep A Test 3) Complete and return the Confirmation of Receipt form via email to RA-OCDUS-CONFIRMAD@QUIDELORTHO.COM If you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or technicalsupport@quidelortho.com.
Quantity in Commerce 22470
DistributionWorldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.
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.
510(K) Database510(K)s with Product Code = GTY
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