FDA Medical Device Recalls (openFDA)
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 number
- Z-1042-05
- Recalling firm
- Core Brands
- 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.
- Status
- Terminated
- Initiated
- 2005-06-22
- Posted
- 2005-07-22
- Terminated
- 2005-11-16
- Reason
- Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2710 cases
- Distribution
- Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LCX
- Firm FEI
- 3004823187
- Firm city
- Baltimore
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28