Recall Z-0531-2009 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Mainline Technology, Inc.
Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
| Date | Jan 15, 2009 (initiated Aug 18, 2008) |
| 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 expiration dates. |
| Root cause | PMA |
| Action | Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08. |
| Quantity | 33919 kits |
| Distribution | Worldwide Distribution --- including USA and countries of Belgium and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.