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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica Solution

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 Class 2 Device Recall Atellica Solutionsee related information
Date Initiated by FirmSeptember 26, 2018
Create DateJanuary 29, 2019
Recall Status1 Terminated 3 on June 24, 2020
Recall NumberZ-0781-2019
Recall Event ID 81380
510(K)NumberK151792 
Product Classification Calibrator, secondary - Product Code JIT
ProductAtellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
Code Information Software in V 1.14.2 and lower.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSAME
914-631-8000
Manufacturer Reason
for Recall		Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime
FDA Determined
Cause 2		Software design
ActionSiemens Healthcare Diagnsotics issue an Urgent Medical Device Correction (UMDC) was issued to US customers via Fed-Ex on September 26, 2018. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. The letter explains the reasons, observed behaviors, risk to health, actions to be taken. Review the letter with the Medical Director. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. The system will be updated with software version- SW V1.15 which resolves issues.
Quantity in Commerce264
DistributionWorldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIT
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