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Terminated

Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.]

FDA Recall Z-2754-2019 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeNHX
Date Initiated2019-08-14
Date Terminated2021-07-28
Product Quantity169 kits

Reason for Recall

Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure

Firm Action

Siemens Healthcare Urgent Medical Device Correction, AIMC 19-02.A.US sent to US customers on August 14, 2019 for delivery on August 15, 2019. Urgent Field Safety Notice, AIMC 19-02.A.OUS was sent out to the country (OUS) organizations on August 13, 2019 to customers outside the United States (US). The customer distribution included all customers that have received both Atellica IM anti-CCP IgG (aCCP) and Atellica IM Testosterone II (US and OUS) and/or both Atellica IM Pregnancy-Associated Plasma Protein-A (PAPP-A) and Atellica IM Testosterone II (OUS only) The letters inform customers that Siemens Healthcare Diagnostics has confirmed the reagent carryover mitigation for the Testosterone II assay is unable to be completed as defined in the aCCP Test Definition (US and OUS) and PAPP-A Test Definition (OUS only). The communications provide options to maintain continuous workflow. If you have any questions, contact your local Siemens Healthineers technical support representative

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution including the states of CA, FL, KY, NH, TX and countries of Austria¿¿¿¿¿¿¿¿ Curacao,¿St¿Eus Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.Axis-Shield Diagnostics Limited · 2016-08-04

Official Source

View FDA Recall →

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

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