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ONLINE TDM Methotrexate
Roche Diagnostics GmbH · Model 09230785190 · UDI-DI 07613336224816
LAO
Prescription
10
510(k) clearances
19
Adverse events
2
Recalls
4
Facilities
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
