Z-0408-06

STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name...

Name: Z-0408-06 STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name...
Creator: Diagnostica Stago, Inc.
Published: 2005-10-26
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2005-10-26 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein... on 2005-10-26. The reason FDA records is "The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0408-06
Status: Terminated
Initiated: 2005-10-26
Posted: 2006-01-20
Terminated: 2006-03-01
Recalling firm: Diagnostica Stago, Inc.
Product: STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
FDA root cause: Other
Action: Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.
Quantity in commerce: 150 units
Distribution: Product was distributed to 23 direct account customers nationwide.
Product codes and lots: Lot 0422671 exp. March 2006.

Product code GGP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)