Home › ARKRAY USA, INC. › ARKRAY Multi-let 2 Lancing Device
ARKRAY Multi-let 2 Lancing Device
ARKRAY USA, INC. · Model 660016 · UDI-DI 00015482660161
1
510(k) clearances
250
Adverse events
1
Recalls
87
Facilities
Description
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-25 | Home Health US, Incorporated | Due to incorrect/lack of Unique Device Identifier (UDI) codes. |
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 docsData 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.