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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM 1300 and Atellica 1600 Analyzers

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  Class 2 Device Recall Atellica IM 1300 and Atellica 1600 Analyzers see related information
Date Initiated by Firm October 26, 2020
Create Date November 19, 2020
Recall Status1 Terminated 3 on April 19, 2024
Recall Number Z-0474-2021
Recall Event ID 86718
510(K)Number K151792  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066000
Code Information Software version: V1.23.1 or lower UDI: 00630414002026
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact SAME
914-631-8000
Manufacturer Reason
for Recall		 Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens issued an Urgent Medical Device Correction (UMDC ASW21-01.A.US) via Fed'X to US Customers on 10/26/20 and Urgent Field Safety Notice, (UFSN ASW21-01.A.OUS) via electronic distribution to regional countries for implementation Outside US (OUS) The UMDC and UFSN explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email. A software version correcting the issues will be released when available and all systems will be updated.
Quantity in Commerce US: 214 units; OUS: 1082 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.
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 = JLW and Original Applicant = Siemens Healthcare Diagnostics,Inc.
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