FDA Device Intelligence
Home › Shenzhen YHLO Biotech Co., Ltd. › iFlash-FT3

iFlash-FT3

Shenzhen YHLO Biotech Co., Ltd. · Model C86018 · UDI-DI 06925912718482

KHQ
10
510(k) clearances
4
Adverse events
1
Recalls
33
Facilities

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.