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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM Analyzer

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  Class 2 Device Recall Atellica IM Analyzer see related information
Date Initiated by Firm April 13, 2022
Create Date June 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1252-2022
Recall Event ID 90153
510(K)Number K151792  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
Siemens Material Number (SMN): 11066001
Code Information UDI: 00630414007960 All lots
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		 Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens issued an Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 04/13/2022 and an Urgent Field Safety Notice (UFSN) was issued to all OUS. Letter states reason for recall, health risk and action to take: If your facility has multiple lots of T3 available for use and some kit lots are below lots ending in 244, follow the steps below to ensure that T3 results will be correct for all available lots until all kit lots available for use are kit lots ending in 244 or above. Ensure that all IM modules connected to an Atellica Solution have only 1 lot of T3 reagent (all IM modules have the same lot of T3 reagent packs) loaded onto every IM. For reagent kit lots below lots ending in 244: Rescan the Master Curve Card (MCC) for the T3 reagent lot that is on the Atellica IM before processing with that reagent lot, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes ). Note: If the IM is rebooted while using kit lots below lots ending in 244, the MCC will need to be re-scanned before samples are processed. For reagent lots ending in 244 and above: Rescan the Master Curve Card (MCC) for the T3 reagent kit lot that is on the Atellica IM, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes . Reboot all IM modules connected to Atellica Solution following instructions in the Atellica Online Help (SMN 11313586, section titled Shutting Down and Powering Off Analyzers within the System ) when changing from reagent kit lots below lots ending in 244 to a reagent pack associated with kit lots ending in 244 or above before processing with that reagent kit lot. Please review this letter with your Medical Director. Complete and return the Field Action Effectiveness Check Form attached to this letter within 30 days.
Quantity in Commerce 1,566
Distribution Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, 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.
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