Diagnostica Stago, Inc. STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
Lot 101393, 101465, 101676, and 102269.
Products Sold
Lot 101393, 101465, 101676, and 102269.
Diagnostica Stago, Inc. is recalling STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, due to Internal investigation has determined the potential lack of homogeneity between product vials.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Internal investigation has determined the potential lack of homogeneity between product vials.
Recommended Action
Per FDA guidance
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 if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026