Recall Z-1526-2022 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Family Dollar Stores, Llc.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
| Date | Aug 17, 2022 (initiated Jun 23, 2022) |
| Status | Open, Classified |
| Reason | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| Root cause | Storage |
| 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 | 128 units |
| Distribution | Product distributed to Family Dollar retail stores in US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200913 | Clearblue® Early Digital Pregnancy Test Spd Swiss Precision Diagnostics GmbH, Aug 13, 2021 |