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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica Solution IM1600 Analyzer

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  Class 2 Device Recall Atellica Solution IM1600 Analyzer see related information
Date Initiated by Firm May 07, 2020
Date Posted June 19, 2020
Recall Status1 Open3, Classified
Recall Number Z-2405-2020
Recall Event ID 85687
510(K)Number K151792  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Code Information Atellica Tube Top Sample Cups, 1 mL, SMN 11069061;  Atellica Tube Top Sample Cups, 2 mL, SMN 11069062;  Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ranjan Sadarangani
914-524-2868
Manufacturer Reason
for Recall		 Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
FDA Determined
Cause 2		 Employee error
Action On May 7, 2020, Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction letter to their Atellica Solution IM1300/IM1600 Analyzer customers. The letter described the precautions to be taken when using the following sample containers: Atellica Tube Top Sample Cups - Siemens SMN 11069061 1mL, the Atellica Tube Top Sample Cups - Siemens SMN 11069062 2mL, and the Sarstedt 62.612 - 15.3 x 92 False Bottom sample tubes. The letter states the following about using any of the identified sample containers: the IM Analyzer has a minimum required sample volume for any reportable result; the volume depends on the sample volume for the assay, the sample volume to prime the sample tip, and the volume of unusable sample for the sample container. In addition, the firm explained that detailed information on how to calculate the minimum required sample volume is available in the Atellica Operator Guide SMN 11069101 Section 9 Sample Management. Siemens recommends following the operating instructions, ensuring that there is sufficient sample available in any sample container, and reviewing the letter with their Medical Director. The firm requested that each consignee complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days and stated that if the noted sample containers are not in use in the consignee's laboratory then, no action is required beyond completion of the Field Correction Effectiveness Check Form. *** Updated 5/3/21 *** On January 27, 2021, the firm distributed Revision B of the recall notice to US customers. The notice described updated instructions regarding system labeling for the issue and actions customers need to take in order to prevent the issue from occurring. Specifically, detailed information on how to calculate the minimum required sample volume is available in the Atellica Operator Guide SMN 11069101 V1.20, Section 9 Sample Management or V1.23 Section 12, Samples, chapter: Sample Volume Requir
Quantity in Commerce 1329
Distribution Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.
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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