• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall FIRST RESPONSE

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall FIRST RESPONSE see related information
Date Initiated by Firm June 23, 2022
Date Posted August 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1537-2022
Recall Event ID 90650
510(K)Number K123436  
Product Classification Kit, test, pregnancy, hcg, over the counter - Product Code LCX
Product FIRST RESPONSE 2 CT, SKU 902343
Code Information All product sold between May 1, 2022 - June 10, 2022.
Recalling Firm/
Family Dollar Stores, Llc.
500 Volvo Pkwy
Chesapeake VA 23320-1604
Manufacturer Reason
for Recall
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
FDA Determined
Cause 2
Action On June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
Quantity in Commerce 77
Distribution Product distributed to Family Dollar retail stores in US nationwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LCX and Original Applicant = CHURCH & DWIGHT CO., INC.