Z-2754-2019Class II

Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 -

Name: Z-2754-2019 Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 -
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2019-08-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-08-14 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of 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... on 2019-08-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2754-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-14
Posted: 2019-09-26
Terminated: 2021-07-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.]
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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
FDA root cause: Under Investigation by 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
Quantity in commerce: 169 kits
Distribution: 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.¿¿¿¿¿¿¿¿¿
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2754-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2754-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-26

Product code NHX

K153551Class IIADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.Axis-Shield Diagnostics Limited / cleared 2016-08-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)