Home › CORGENIX MEDICAL CORPORATION › REAADS Coagulation Control 1

REAADS Coagulation Control 1

CORGENIX MEDICAL CORPORATION · Model 701-001 · UDI-DI 00855360006243

GIZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use. PRINCIPLE OF THE PROCEDURE Coagulation Control 1 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.

Recalls

Date	Firm	Reason
2019-11-18	Diagnostica Stago, Inc.	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for fact

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 key Read 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.