Z-1042-05

Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip...

Name: Z-1042-05 Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box, containing one test strip...
Creator: Core Brands
Published: 2005-06-22
License: https://open.fda.gov/license/

Core Brands / initiated 2005-06-22 / Terminated

FDA source

Core Brands began a recall of 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... on 2005-06-22. The reason FDA records is "Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1042-05
Status: Terminated
Initiated: 2005-06-22
Posted: 2005-07-22
Terminated: 2005-11-16
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.
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
FDA 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 in commerce: 2710 cases
Distribution: Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
Product codes and lots: All lots

Product code LCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)