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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

DateFirmReason
2016-03-08Siemens 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
2007-03-20Abbott 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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Data 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.