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ARK™ Methotrexate Assay
ARK DIAGNOSTICS INC · Model 5026-0001-02 · UDI-DI 00858724003254
LAO
Prescription
1
510(k) clearances
19
Adverse events
2
Recalls
4
Facilities
Description
The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-08 | Siemens Healthcare Diagnostics, Inc. | 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 us |
| 2007-03-20 | Abbott Diagnostic International, Ltd. | Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P. |
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