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Terminated

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.

FDA Recall Z-1044-2012 · Posted 2012-02-16

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGGN
Date Initiated2011-08-23
Date Terminated2013-09-04
Product Quantity1259 units

Reason for Recall

Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution and USA (Nationwide) and including Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943518STA SYSTEM CONTROL [N] + [P] KITAmerican Bioproducts Co. · 1995-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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