Devices

Device Recall Abbott RealTime HIV1 Assay

Model / Serial
All in date lots
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA || The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
Manufacturer
Abbott Molecular
1 Event
- Recall of Device Recall Abbott RealTime HIV1 Assay

Manufacturer

Abbott Molecular

Manufacturer Address
Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
Source
USFDA

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