• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Mass Creatine Kinase (MMB) Flex

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Dimension Vista Mass Creatine Kinase (MMB) 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-1672-2018
Recall Event ID 79505
510(K)Number K143720  
Product Classification Colorimetric method, cpk or isoenzymes - Product Code JHY
Product Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
Code Information MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097  Lot codes: 16284BD 16312BB 17011BD 17058BD 17093BC 17136BE 17186BE 17235BC 17268BA 
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ms. Aarti M. Aziz
Manufacturer Reason
for Recall
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
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 = JHY and Original Applicant = Siemens Healthcare Diagnostics