FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Neoplastine CI Plus 10; Product Catalogue Number: 0667 Manufactured by Diagnostica Stago, Asnieres, France.
- Recall number
- Z-0502-2009
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Neoplastine CI Plus 10; Product Catalogue Number: 0667 Manufactured by Diagnostica Stago, Asnieres, France.
- Status
- Terminated
- Initiated
- 2008-10-20
- Posted
- 2008-12-18
- Terminated
- 2010-06-24
- 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 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.
- Quantity
- 31,207 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot 100439, Lot 101126, Lot 101601, Lot 100755, Lot 101231, Lot 101602, Lot 100975, Lot 101419, Lot 101726, Lot 100995, Lot 101420, Lot 101856, Lot 101002, Lot 101600, and Lot 101955.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28