# FDA recall Z-2754-2019

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2019-08-14.

## 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.]

## 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

## 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.¿¿¿¿¿¿¿¿¿

## Key facts

- **Recall number:** Z-2754-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-14
- **Report date:** 2019-10-02
- **Termination date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2754-2019

## Citation

> AI Analytics. FDA recall Z-2754-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2754-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*