Recall Z-0501-2009 ยท GJS Test, Time, Prothrombin
Diagnostica Stago, Inc.
STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.
| Date | Dec 18, 2008 (initiated Oct 20, 2008) |
| Status | Terminated |
| Reason | Internal investigation has determined the potential lack of homogeneity between product vials. |
| Root cause | Process control |
| Action | Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached "Product Recall Response Form" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory i |
| Quantity | 1,280 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.