—#144546

Product

Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.

FDA product code: LAO — Enzyme Immunoassay, Methotrexate
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K811459
Affected lot / code info: Lot # F1, F2, G1, G2, H1, and H2

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-03-08
Posted by FDA: 2016-05-06
Terminated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.