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U.S. Department of Health and Human Services

Class 2 Device Recall CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT

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 Class 2 Device Recall CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CTsee related information
Date Initiated by FirmOctober 04, 2023
Date PostedNovember 07, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0261-2024
Recall Event ID 93216
510(K)NumberK200913 
Product Classification Kit, test, pregnancy, hcg, over the counter - Product Code LCX
ProductCLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Code Information All units sold at stores between June 1, 2023 and October 4, 2023.
Recalling Firm/
Manufacturer		 Family Dollar Stores, Llc.
500 Volvo Pkwy
Chesapeake VA 23320-1604
For Additional Information ContactCustomer Service
844-636-7687
Manufacturer Reason
for Recall		Products were stored outside of labeled temperature requirements.
FDA Determined
Cause 2		Storage
ActionOn October 4, 2023, Family Dollar notified affected stores. Stores were instructed to check stock and quarantine and discontinue the sale of any affected product. Family Dollar's recall notice was posted online: https://www.familydollar.com/file/general/Posting%20for%20website%2010.6.23%20(2)[3].pdf Affected product was sold at these stores between June 1, 2023 and October 4, 2023. Customers who purchased affected product may return the product to the Family Dollar store where they were purchased without receipt. Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9 a.m. and 5 p.m. EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
Quantity in Commerce329,044 total units
DistributionDistributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
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 = LCX
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