Recall Z-2134-2019— Hycor Biomedical Inc

Name: FDA recall Z-2134-2019
Creator: U.S. Food and Drug Administration
Published: 2018-02-21

Class II · Completed

Class II FDA medical device recall by Hycor Biomedical Inc, initiated 2018-02-21. It names one FDA 510(k) clearance: K994338. Product: AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.. Reason: Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor..

Recalling firm: Hycor Biomedical Inc
Classification: Class II
Status: Completed
Initiated: 2018-02-21
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

AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

Reason for recall

Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.

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