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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista CSA and CSAE

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 Class 2 Recall
Dimension Vista CSA and CSAE
see related information
Date Posted May 21, 2014
Recall Status1 Open
Recall Number Z-1647-2014
Recall Event ID 67787
Premarket Notification
510(K) Number
K062236 
Product Classification Cyclosporine - Product Code MKW
Product Dimension Vista® CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Code Information CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall
A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista¿ CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Siemens sent an Urgent Medical Device Correction letter dated March 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the SSC with patient samples when running CSE or CSAE. Siemens also recommended a look back at previously generated CSA or CSAE results if the patient samples have been run from the SSC and that the content of this letter should be discussed with the Medical Director. Customers were asked to complete the attached form and fax it to (302) 631-8467. For questions regarding this recall call 800-441-9250. On/about August 2014, Siemens expanded the recal to include all within-expiry lots of Dimension Vista HbA1c based on further testing that revealed using the SSC with HbA1c yields more variable results than those derived from the primary tubes or sample cups. A recall notification letter, dated August 2014 was sent to customers, notifying them of the recall expansion and providing similar instructions for disposition of the affected lots, response to Siemens, and internal discussion of the letter with the Medical Director.
Quantity in Commerce 4175
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan. List of countries identified for expansion: Australia Austria Belgium Canada Czech Republic Finland France Germany Italy Japan Korea New Zealand Norway Portugal Saudi Arabia Slovakia Spain Switzerland .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKW and Original Applicant = DADE BEHRING, INC.
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