—#176028

Product

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 product code: NHX — Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K153551
Affected lot / code info: All lots

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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.¿¿¿¿¿¿¿¿¿

Timeline

Recall initiated: 2019-08-14
Terminated: 2021-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176028. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.