Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of metho

FDA device recall Z-1618-2016 · posted 2016-05-06 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LAO

Quantity affected

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 Swit

Date initiated

2016-03-08

Date posted

2016-05-06

Date terminated

2017-08-07

Location

Newark, DE

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