Recall Z-0909-05 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Harmony Brands Llc
B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
| Date | Jun 21, 2005 (initiated Mar 25, 2005) |
| Status | Terminated |
| Reason | Lack of assurance of safety and efficacy; products are from unknown sources. |
| Root cause | Other |
| Action | Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05. |
| Quantity | unknown. |
| Distribution | United States . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.