FDA Device Intelligence
Home › Siemens Healthcare Diagnostics Inc. › Dimension® Flex® reagent cartridge TU

Dimension® Flex® reagent cartridge TU

Siemens Healthcare Diagnostics Inc. · Model 10444912 · UDI-DI 00842768005695

KHQCIG
1
510(k) clearances
4
Adverse events
1
Recalls
33
Facilities

Description

Thyronine Uptake Flex® reagent cartridge, 160 tests

Recalls

DateFirmReason
2018-03-05Tosoh Bioscience IncAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

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.