Z-1044-2012

STA - System Control N + P

Name: Z-1044-2012 STA - System Control N + P
Creator: Diagnostica Stago, Inc.
Published: 2011-08-23
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2011-08-23 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control... on 2011-08-23. The reason FDA records is "Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P". 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-1044-2012
Status: Terminated
Initiated: 2011-08-23
Posted: 2012-02-16
Terminated: 2013-09-04
Recalling firm: Diagnostica Stago, Inc.
Product: STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.
Product code: GGN Plasma, Coagulation Control
Reason for recall: Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.
Quantity in commerce: 1259 units
Distribution: Worldwide Distribution and USA (Nationwide) and including Canada
Product codes and lots: K9483518 D029396 Lot #106775

Product code GGN

K943518Class IISta System Control [N] + [P] KitAmerican Bioproducts Co. / cleared 1995-03-21

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)