| Class 2 Device Recall Atellica IM Analyzer | |
Date Initiated by Firm | April 13, 2022 |
Create Date | June 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1253-2022 |
Recall Event ID |
90153 |
510(K)Number | K151792 |
Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
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Product | Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens
Siemens Material Number (SMN): 11066000 |
Code Information |
UDI: 00630414002026
All lots |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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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 | 2,321 |
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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JLW
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