Recall Z-0266-2024— Family Dollar Stores, Llc.

Name: FDA recall Z-0266-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Class II · Ongoing

Class II FDA medical device recall by Family Dollar Stores, Llc., initiated 2023-10-04. It names one FDA 510(k) clearance: K123436. Product: FIRST RESPONSE 2 CT, SKU 902343. Reason: Products were stored outside of labeled temperature requirements..

Recalling firm: Family Dollar Stores, Llc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-04
Firm location: Chesapeake, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K123436 — FIRST RESPONSE EARLY RESULT PREGNANCY TESTChurch & Dwight Co., Inc.·cleared 2013-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FIRST RESPONSE 2 CT, SKU 902343

Reason for recall

Products were stored outside of labeled temperature requirements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.