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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Atellica IM 1600 Analyzer

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  Class 2 Device Recall Siemens Atellica IM 1600 Analyzer see related information
Date Initiated by Firm May 13, 2021
Create Date July 07, 2021
Recall Status1 Open3, Classified
Recall Number Z-2028-2021
Recall Event ID 88056
510(K)Number K151792  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066000
Code Information Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx  Note: xxxx in serial number is any number.     UDI: 00630414002026 
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
FDA Determined
Cause 2
Component design/selection
Action Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021. Letter states: Actions to be Taken by the Customer The following actions must be taken until your system has been serviced to replace any leaking components. 1. When reporting results, ensure that all QC results are within the laboratory acceptable range before releasing results. A manufacturing defect in some valves may cause them to leak Siemens Healthcare Diagnostics Inc. 2. On the Atellica CH930 Analyzer: If any water droplets are observed on the tips of any Reaction Wash Station or Dilution Wash Station probes, contact Siemens service so that the instrument can be checked for valves that may be failing. 3. On the Atellica IM 1300 or Atellica IM 1600 Analyzers: If any water droplets are observed forming at the tips of any Reagent probes, contact Siemens service so that the instrument can be checked for valves that may be failing. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Technical Support representative. Siemens Service representative will be contacting your laboratory to check and replace the identified valves. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Contact your Siemens Healthineers Customer Care Center or y
Quantity in Commerce US: 123 OUS: 751
Distribution Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R. China Pakistan Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. Uganda 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 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 = JLW and Original Applicant = Siemens Healthcare Diagnostics,Inc.