Recall Z-1042-05 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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.
| Date | Jul 22, 2005 (initiated Jun 22, 2005) |
| Status | Terminated |
| 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.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.