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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Thyroid Stimulating Hormone (TSHL) Flex

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  Class 2 Device Recall Dimension Thyroid Stimulating Hormone (TSHL) Flex see related information
Date Initiated by Firm January 02, 2018
Date Posted May 04, 2018
Recall Status1 Open3, Classified
Recall Number Z-1668-2018
Recall Event ID 79505
510(K)Number K140842  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Code Information TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524  Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261 
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ms. Aarti M. Aziz
914-631-8000
Manufacturer Reason
for Recall
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
FDA Determined
Cause 2
Error in labeling
Action Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Distribution Nationwide and Canada, Mexico, and Thailand
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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