Recall Z-2754-2019— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2754-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-14

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2019-08-14, terminated 2021-07-28. It names one FDA 510(k) clearance: K153551. 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: 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.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-08-14
Terminated: 2021-07-28
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.Axis-Shield Diagnostics Limited·cleared 2016-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.