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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 22, 2005
Date PostedJuly 22, 2005
Recall Status1 Terminated 3 on November 16, 2005
Recall NumberZ-1042-05
Recall Event ID 32525
Product Classification Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
ProductHealing 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.
Code Information All lots
FEI Number 3004823187
Recalling Firm/
Manufacturer		 Core Brands
1301 Wicomico Street
Baltimore MD 21230-2000
For Additional Information ContactMichael Resnick
410-837-4005
Manufacturer Reason
for Recall		Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce2710 cases
DistributionProduct was sold to distributors and retailers in MI, NY, MD, MA, PA, NJ and RI..
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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