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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex

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  Class 2 Device Recall Dimension Vista Thyroid Stimulating Hormone (TSH) Flex see related information
Date Initiated by Firm January 02, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on February 10, 2023
Recall Number Z-1673-2018
Recall Event ID 79505
510(K)Number K140859  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Code Information TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524  Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA 
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = Siemens Healthcare Diagnostics Inc.
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