STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.

FDA device recall Z-0501-2009 · posted 2008-12-18 · Terminated

Recall details

Recalling firm

Diagnostica Stago, Inc.

Reason for recall

Internal investigation has determined the potential lack of homogeneity between product vials.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

GJS

Quantity affected

1,280 units

Distribution

Nationwide Distribution.

Date initiated

2008-10-20

Date posted

2008-12-18

Date terminated

2010-06-24

Location

Parsippany, NJ