Recall Z-1618-2016 ยท LAO Enzyme Immunoassay, Methotrexate
Siemens Healthcare Diagnostics, Inc.
Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
| Date | May 6, 2016 (initiated Mar 8, 2016) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811459 | EMIT-AND METHOTREXATE ASSAY Syva Co., Jun 9, 1981 |