| Date Initiated by Firm | August 31, 2005 |
|---|
| Date Posted | October 06, 2005 |
|---|
| Recall Status1 |
Terminated 3 on March 16, 2012 |
| Recall Number | Z-0006-06 |
|---|
| Recall Event ID |
33412 |
| Product Classification |
System, Test, Human Chorionic Gonadotropin - Product Code DHA
|
| Product | Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052) |
|---|
| Code Information |
Lot#62-500261 |
| FEI Number |
2050095
|
Recalling Firm/
Manufacturer |
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente CA 92673-6316
|
| For Additional Information Contact | John Chiechi
949-940-7377 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 22 |
|---|
| Distribution | Nationwide and China, Germany, & Australia |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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