Recall Z-1018-2010 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Mainline Technology, Inc.
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
| Date | Mar 8, 2010 (initiated Oct 7, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | PMA |
| Action | 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. |
| Quantity | Information not provided. |
| Distribution | Worldwide Distribution -- United States, Belgium and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.