Z-1618-2016Class II

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

Name: Z-1618-2016 Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-03-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-03-08 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma on 2016-03-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1618-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-08
Posted: 2016-05-06
Terminated: 2017-08-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
Product code: LAO Enzyme Immunoassay, Methotrexate
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 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 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.
Product codes and lots: Lot # F1, F2, G1, G2, H1, and H2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1618-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1618-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

Product code LAO

K811459UnclassifiedEmit-and Methotrexate AssaySyva Co. / cleared 1981-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)