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U.S. Department of Health and Human Services

Class 2 Device Recall Syva Emit Methotrexate Assay

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  Class 2 Device Recall Syva Emit Methotrexate Assay see related information
Date Initiated by Firm March 08, 2016
Date Posted May 06, 2016
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-1618-2016
Recall Event ID 73594
510(K)Number K811459  
Product Classification Enzyme immunoassay, methotrexate - Product Code LAO
Product Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
Code Information Lot # F1, F2, G1, G2, H1, and H2
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Richard Andersen
302-631-0528
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens mailed an Urgent Medical Device Correction letter to customers informing them that they were withdrawing the Emit Methotrexate Application on the Dimension Vista System. Customers were asked to contact their local Siemens sales representative for alternative testing solutions for Methotrexate. Siemens advised customers to change the On-Board Stability for the Methotrexate application on the Dimension Vista System to four hours: alternatively, customers can run the Methotrexate application in batch mode, along with QC. It was also requested in the notification that customers complete and return the Field Correction Effectiveness Check Form that was attached with the notification within 30 days.
Quantity in Commerce 18364 units
Distribution Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.
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 = LAO and Original Applicant = SYVA CO.
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