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ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents

Siemens Healthcare Diagnostics Inc. · Model 10376932 · UDI-DI 00630414561677

KLB
1
510(k) clearances
2
Adverse events
2
Recalls
8
Facilities

Description

Tobramycin - ADVIA Chem. - RGT - 4x100 tests

Recalls

DateFirmReason
2007-04-05Roche Diagnostics Corp.Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Onli
2007-04-05Roche Diagnostics Corp.Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Onli

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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.