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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Iron Flex reagent cartridge

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  Class 3 Device Recall Dimension Iron Flex reagent cartridge see related information
Date Initiated by Firm August 25, 2016
Create Date November 11, 2016
Recall Status1 Terminated 3 on December 01, 2017
Recall Number Z-0402-2017
Recall Event ID 75256
510(K)Number K060264  
Product Classification Photometric method, iron (non-heme) - Product Code JIY
Product Dimension IRON Flex reagent cartridges
Code Information Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
FDA Determined
Cause 2		 Error in labeling
Action Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.
Quantity in Commerce 38,230 cartridges
Distribution Distributed Nationwide
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 = JIY and Original Applicant = DADE BEHRING, INC.
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