Core Brands Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip and materials for one test, and labeled in part ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.
Brand
Core Brands
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Core Brands is recalling Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test due to Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
Recommended Action
Per FDA guidance
The recalling firm notified distributors by phone on 06/17/05 to hold product and followed with a letter and fax to distributors and direct account retailers on 06/21/05. Notification instructed distributors and retailers to discontinue selling the product and return product. Distributors were requested to notify all of their consignees with the 'retailer alert' notification provided.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MD, MA, MI, NJ, NY, PA, RI
Page updated: Jan 10, 2026