510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0261-2024Class II

Clearblue Smart Countdown Prgncy Tst 1Ct, Sku 900260

Family Dollar Stores / initiated 2023-10-04 / Open, Classified / root cause: labeling and UDI
FDA source (opens on fda.gov)

Family Dollar Stores, Llc. began a recall of CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 on . FDA classified it as Class II and gives the reason as "Products were stored outside of labeled temperature requirements". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0261-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Family Dollar Stores
Product
Clearblue Smart Countdown Prgncy Tst 1Ct, Sku 900260
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall
Products were stored outside of labeled temperature requirements.
Root cause tag
labeling and UDI
FDA root cause
Storage
Action
On 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 commerce
329,044 total units
Distribution
Distributed 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.
Product codes and lots
All units sold at stores between June 1, 2023 and October 4, 2023.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0261-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0261-2024Class IIOngoingVoluntary: Firm initiated
Z-0262-2024Class IIOngoingVoluntary: Firm initiated
Z-0263-2024Class IIOngoingVoluntary: Firm initiated
Z-0264-2024Class IIOngoingVoluntary: Firm initiated
Z-0265-2024Class IIOngoingVoluntary: Firm initiated
Z-0266-2024Class IIOngoingVoluntary: Firm initiated
Z-0267-2024Class IIOngoingVoluntary: Firm initiated
Z-0268-2024Class IIOngoingVoluntary: Firm initiated
Z-0269-2024Class IIOngoingVoluntary: Firm initiated
Z-0270-2024Class IIOngoingVoluntary: Firm initiated