Mainline Technology, Inc. Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
Brand
Mainline Technology, Inc.
Lot Codes / Batch Numbers
Lot 25310 and 25831.
Products Sold
Lot 25310 and 25831.
Mainline Technology, Inc. is recalling Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026