URGENT: Medical Device Recall
Alere INRatio PT/INR Professional Test Strips (PN 99008G2)
Please view the Recall Notice [830KB, PDF] for important information
Manager, Laboratory Licensure Unit
Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
Florida Relay Service (TDD): (800) 955-8771
Fax: (850) 410-1511
All facilities, including physician offices, performing any clinical laboratory testing, are required to obtain a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. Facilities performing any non-waived clinical laboratory testing or testing using a microscope must also obtain a state clinical laboratory license before the laboratory is authorized to perform testing. Tests performed using a microscope are not waived. To determine whether a test is waived, see the List of Waived Tests at the federal web site: http://www.cms.hhs.gov/CLIA/10_Categorization_of_Tests.asp, which provides CLIA categorizations.
Although CLIA, CMS116 forms are a part of laboratory applications and are submitted to the state, the CLIA program separately bills the laboratory for payment. CLIA fees should never be sent to the State of Florida.
A notice of workshop was published on 11/18/2016 in Vol. 42/225 of the Florida Administrative Register.
The Agency proposes to amend the rule to provide clarification to the definition of an Exclusive Use Laboratory.
The notice may be accessed at the following link: https://www.flrules.org/Gateway/View_notice.asp?id=18277533.
Click here for a copy of the agenda.