FDA recall Z-2200-2019

Hycor Biomedical Inc · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2018-03-19
Report date
2019-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Garden Grove, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2200-2019