Recall Z-2200-2019— Hycor Biomedical Inc

Name: FDA recall Z-2200-2019
Creator: U.S. Food and Drug Administration
Published: 2018-03-19

Class II · Ongoing

Class II FDA medical device recall by Hycor Biomedical Inc, initiated 2018-03-19. It names one FDA 510(k) clearance: K994338. 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: 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..

Recalling firm: Hycor Biomedical Inc
Classification: Class II
Status: Ongoing
Initiated: 2018-03-19
Firm location: Garden Grove, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISACogent Diagnotics , Ltd.·cleared 2000-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.