Recall Z-0003-2007 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Axis-Shield Diagnostics, Ltd.
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
| Date | Oct 3, 2006 (initiated Nov 11, 2005) |
| Status | Terminated |
| Reason | The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%. |
| Root cause | Other |
| Action | Advisory letter was sent to customers informing them of the increased sodium azide content. A specific letter was sent to each customer / distributor informing them of the misformulation. The content of the letter referred to the specific kits received by each customer. The letter informed users about the additional risk relating to double azide concentration. The outcome of the risk evaluation was as follows: 1) There is no impact to product performance and hence patient results because of this. 2) The increase in the sodium azide concentration changes the hazard status from ''No significa |
| Quantity | 2,288 Kits |
| Distribution | Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India. |
| FDA record | Open on fda.gov |