Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
FDA device recall Z-0007-06 · posted 2005-10-06 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHA
- Quantity affected
- 174
- Distribution
- Nationwide and China, Germany, & Australia
- Date initiated
- 2005-08-31
- Date posted
- 2005-10-06
- Date terminated
- 2012-03-16
- Location
- San Clemente, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (K042676) | Nichols Institute Diagnostics | 2004-12-17 |