Home › SEPARATION TECHNOLOGY, INC. › UltraCrit QC Cuvettes
UltraCrit QC Cuvettes
SEPARATION TECHNOLOGY, INC. · Model 270-112 · UDI-DI 00831829000045
GKF
Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
21
Facilities
Description
UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultasound technology to accurately measure hematocrit (Hct) in whole blood.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-05-24 | Radiometer America Inc | The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the |
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.