URGENT: Medical Device Recall
Alere INRatio PT/INR Professional Test Strips (PN 99008G2)
Please view the Recall Notice [830KB, PDF] for important information
Any laboratory conducting waived tests only must have a valid CLIA Certificate of Waiver. To apply for a CLIA Certificate of Waiver complete a Centers for Medicare and Medicaid Services Form CMS-116 [1.10MB] and mail it to the Agency at the address to the right.
To check to see if a test is "waived", CMS advises that it can be checked on the Food and Drug Administration's web site and provides a PDF file of waived laboratory tests as well.
Examples of waived tests include:
- Dip stick urinalysis or tablet reagent urinalysis (non-automated or certain automated analyzers)
- Fecal occult blood
- Urine pregnancy tests
- Erythrocyte sedimentation rate (ESR) non-automated
- Blood glucose- devices cleared by the Food and Drug Administration of home use
Federal Requirements for a Certificate of Waiver:
The Centers for Medicare and Medicaid Services (CMS) administers the CLIA laboratory certification program in conjunction with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). All facilities performing any clinical laboratory testing are required to obtain a CLIA certificate. Waived testing laboratories:
- Employs methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
- Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
- Are cleared by the FDA for home use.
- Conduct testing that is considered non-technical requiring little or no difficulty.
Federal publication to help Certificate of Waiver providers to perform tests: Ready Set Test Booklet [1.48MB, PDF]
Requirements for Laboratories Performing Only Waived Tests:
- CLIA Certificate of Waiver renewed every 2 years.
- Follow manufacturer's instructions and document tests performed.
- Waived laboratories are not inspected except on a random basis for the CLIA program.
- There are no requirements for directors of waived laboratories.
- Submit a new Federal CLIA application (FORM CMS-116) for:
- Initial Application
- Reinstatement Application if there is a gap in service
- Written notification of changes (always provide the CLIA ID number):
- Change in name of the laboratory.
- Change in address, whether street address or mailing address
- Change in telephone or fax number
- Change in Ownership
- Change in Tax ID
- Reinstatement if these is no gap in service (please call our office if you are unsure if there is a gap)
- Change in accreditation organization
- Voluntary closure/termination
NOTE: A Form CMS-116 can be submitted when written notification is required. If the CMS-116 is used in lieu of written notification, it must be completed in it entirety to be accepted. Written notification includes email, fax or hard copy letter.