Hycor Biomedical Inc: Medical Device Recall in 2019 - (Recall #: Z-2200-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 19, 2018

Date Posted: August 14, 2019

Recall Number: Z-2200-2019

Event ID: 83268

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.

Status: Ongoing

Product Quantity: 288

Code Information:

All lots of RF assay

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated