Events

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 Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USAMade in ChinaUPC 087399430205. Packed 48 boxes/case.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Core Brands.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Event ID
32525
Event Risk Class
Class 2
Event Number
Z-1042-05
Event Initiated Date
2005-06-22
Event Date Posted
2005-07-22
Event Status
Terminated
Event Country
United States
Event Terminated Date
2005-11-16
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40277
Notes / Alerts

U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data

Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
Reason
Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
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.

Device

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

Model / Serial
All lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Product was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
Product Description
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.
Manufacturer
Core Brands

Manufacturer

Core Brands

Manufacturer Address
Core Brands, 1301 Wicomico Street, Baltimore MD 21230-2000
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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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 ***Distributed by Core Brands, 1301 Wicomico St Baltimore, MD 21230 USA***Made in China***UPC 087399430205***. Packed 48 boxes/case.