Z-0501-2009

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

Name: Z-0501-2009 STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France
Creator: Diagnostica Stago, Inc.
Published: 2008-10-20
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2008-10-20 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France on 2008-10-20. The reason FDA records is "Internal investigation has determined the potential lack of homogeneity between product vials". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0501-2009
Status: Terminated
Initiated: 2008-10-20
Posted: 2008-12-18
Terminated: 2010-06-24
Recalling firm: Diagnostica Stago, Inc.
Product: STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Internal investigation has determined the potential lack of homogeneity between product vials.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,280 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot 101393, 101465, 101676, and 102269.

Product code GJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)