| Date Initiated by Firm |
August 14, 2019 |
| Create Date |
September 26, 2019 |
| Recall Status1 |
Terminated 3 on July 28, 2021 |
| Recall Number |
Z-2754-2019 |
| Recall Event ID |
83653 |
| 510(K)Number |
K153551
|
| Product Classification |
Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
|
| 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.] |
| Code Information |
All lots |
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
|
| For Additional Information Contact |
SAME
508-668-5000
|
Manufacturer 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 Determined
Cause 2 |
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
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| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = NHX and Original Applicant = Axis-Shield Diagnostics Limited.
|
