Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
FDA device recall Z-1018-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Mainline Technology, Inc.
- 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.
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- Information not provided.
- Distribution
- Worldwide Distribution -- United States, Belgium and Switzerland.
- Date initiated
- 2009-10-07
- Date posted
- 2010-03-08
- Date terminated
- 2011-02-04
- Location
- Ann Arbor, MI
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