Recall Z-1018-2010
Mainline Technology, Inc. · initiated October 7, 2009
Product
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
Codes / lots: Lot 25310 and 25831.
Reason for recall
Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.
FDA-determined cause: PMA
Action taken
Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.
Details
- Recall number
- Z-1018-2010
- Initiated
- October 7, 2009
- Posted by FDA
- March 8, 2010
- Terminated
- February 4, 2011
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Quantity
- Information not provided.
- Distribution
- Worldwide Distribution -- United States, Belgium and Switzerland.
- Recalling firm
- Mainline Technology, Inc., Ann Arbor, MI