Z-2134-2019Class II

AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05

Name: Z-2134-2019 AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05
Creator: Hycor Biomedical Inc
Published: 2018-02-21
License: https://open.fda.gov/license/

Hycor Biomedical / initiated 2018-02-21 / Completed / root cause: manufacturing process

FDA source

Hycor Biomedical Inc began a recall of 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... on 2018-02-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2134-2019
Classification: Class II
Status: Completed
Initiated: 2018-02-21
Posted: 2019-07-30
Recalling firm: Hycor Biomedical
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.
Product code: DHR System, Test, Rheumatoid Factor
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 02/21/19, Urgent Field Safety Notices were mailed to customers advising them to immediately discontinue testing and to either return or destroy remaining affected product. Further, customers were advised to share this information with laboratory staff, retain this notification as part of their laboratory documentation, and to complete and return the Field Safety Notice & Acknowledgement Form. Customers with additional questions were encouraged to call: 714-933-3000
Quantity in commerce: 207
Distribution: U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
Product codes and lots: Lot Number 154962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2019	Class II	Completed	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code DHR

K994338Class IIAutostat II Rheumatoid Factor Igm ElisaCogent Diagnotics , Ltd. / cleared 2000-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)