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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica solution, Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer

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  Class 2 Device Recall Atellica solution, Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer see related information
Date Initiated by Firm December 02, 2020
Create Date January 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0862-2021
Recall Event ID 86970
510(K)Number K151792  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Code Information Software (SW) versions V1.23.2 (SMN 11469032) or lower
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		 Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens has issued an Urgent Medical Device Correction letter (UMDC ASW21-02.A.US) and Urgent Field Safety Notice, (UFSN ASW21-02.A.OUS) to all affected Customers stating reason for recall, health risk and action to take: Software version 1.24.x correcting the issues will be released when available and all systems will be updated. The following actions must be taken until your system has been updated to software version 1.24 or higher which resolves the issues listed below. Siemens Healthineers will notify you when an updated software version is available. Issue Number 1: Patient sample may be run on analyzer where it was disabled. 1. When reporting results, ensure that the result for the assay that is disabled on one analyzer, came from a system where the assay had not been disabled and all QC results are within the laboratory acceptable range. 2. To check if an assay is enabled or disabled, navigate to Setup/>/Test Definition/>/Assay List/>/CH or IM tab./An assay is/enabled if the box is checked in the column/for an analyzer. 3. The Audit Trail screen (System->Logs->Audit Trail.Log) can be checked to see if an assay had been disabled in the past. Issue Number 2: Bypass mode  patient samples may be run. 1. Always ensure that the system covers are properly physically closed and latched. The lock glyph on the System > Status/screen for an analyzer indicates whether the cover is locked or/unlocked. Ensure that there are no yellow unlocked glyphs displayed. 2. Before starting/sample processing,/check/the Operator Event log and ensure that the following error code is not present: 03 600 00 44: A cover is open with the Service Bypass Tools in place. Ensure all operators are clear of moving subassemblies to avoid personal injury or system damage. Corrective Action: Contact the local technical support provider for assistance./ Refer to the online help Alerts section 03 IM Event Troubleshooting if the error code is present. Issue Number
Quantity in Commerce 1095 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, 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, Vatika City, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = Siemens Healthcare Diagnostics,Inc.
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