Class 2 Device Recall BSure

• Date Initiated by Firm: March 25, 2005
• Date Posted: June 21, 2005
• Recall Status: Terminated on April 17, 2007
• Recall Number: Z-0909-05
• Recall Event ID: 31500
• Product Classification: Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
• Product: B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Harmony Brands Llc; 13240 Capital St; Oak Park MI 48237-3159
• For Additional Information Contact: Sonia Mackie; 248-582-9800
• Manufacturer Reason for Recall: Lack of assurance of safety and efficacy; products are from unknown sources.
• FDA Determined Cause: Other
• Action: Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
• Quantity in Commerce: unknown.
• Distribution: United States .
• Total Product Life Cycle: TPLC 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.