Z-1072-2007

STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica...

Name: Z-1072-2007 STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica...
Creator: Diagnostica Stago, Inc.
Published: 2007-05-08
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2007-05-08 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone... on 2007-05-08. The reason FDA records is "Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1072-2007
Status: Terminated
Initiated: 2007-05-08
Posted: 2007-08-09
Terminated: 2010-10-13
Recalling firm: Diagnostica Stago, Inc.
Product: STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
FDA root cause: Other
Action: Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
Quantity in commerce: 365 units
Distribution: Medical facilities nationwide
Product codes and lots: Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07; 061991, Exp 8/31/07; 062633, Exp 10/31/07; 063281, Exp 12/31/07

Product code GGP

K912468Class IILiatest Protein S KitAmerican Bioproducts Co. / cleared 1991-10-02

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)