Home / Recalls / Hycor Biomedical Inc / Z-2200-2019

Z-2200-2019 Class II Ongoing

Recalled by Hycor Biomedical Inc — Garden Grove, CA

Recall Details

Product Type: Devices
Report Date: August 14, 2019
Initiation Date: March 19, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 288

Product Description

HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

Reason for Recall

Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.

Distribution Pattern

Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India

Code Information

All lots of RF assay