Recall Z-0007-06 ยท DHA System, Test, Human Chorionic Gonadotropin
Nichols Institute Diagnostics
Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
| Date | Oct 6, 2005 (initiated Aug 31, 2005) |
| Status | Terminated |
| Reason | Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. |
| Root cause | Other |
| Action | Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included. |
| Quantity | 174 |
| Distribution | Nationwide and China, Germany, & Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY Nichols Institute Diagnostics, Dec 17, 2004 |