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Terminated

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

FDA Recall Z-2650-2014 · Posted 2014-09-16

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeKFF
Date Initiated2014-07-18
Date Terminated2015-01-16
Product Quantity514 kits

Reason for Recall

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Firm Action

Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed USA (nationwide) and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc. · 2011-10-26

Official Source

View FDA Recall →

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

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