Z-0266-2024Class II

First Response 2 CT, Sku 902343

Name: Z-0266-2024 First Response 2 CT, Sku 902343
Creator: Family Dollar Stores, Llc.
Published: 2023-10-04
License: https://open.fda.gov/license/

Family Dollar Stores / initiated 2023-10-04 / Open, Classified / root cause: labeling and UDI

FDA source

Family Dollar Stores, Llc. began a recall of FIRST RESPONSE 2 CT, SKU 902343 on 2023-10-04. FDA classified it as Class II and gives the reason as "Products were stored outside of labeled temperature requirements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0266-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-04
Posted: 2023-11-07
Recalling firm: Family Dollar Stores
Product: First Response 2 CT, Sku 902343
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-0266-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0261-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0262-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0263-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0264-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0265-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0266-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0267-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0268-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0269-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07
Z-0270-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07

Product code LCX

K123436Class IIFirst Response Early Result Pregnancy TestChurch & Dwight Co., Inc. / cleared 2013-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)