FDA Device Intelligence
HomeRoche Diagnostics GmbH › ONLINE TDM Tobramycin

ONLINE TDM Tobramycin

Roche Diagnostics GmbH · Model 08253161190 · UDI-DI 07613336147948

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

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.