FDA Medical Device Recalls (openFDA)
Hycor Biomedical Inc: 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.
- Recall number
- Z-2134-2019
- Recalling firm
- Hycor Biomedical Inc
- 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.
- Status
- Completed
- Initiated
- 2018-02-21
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 207
- Distribution
- U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
- Lot, serial or model codes
- Lot Number 154962
- 510(k) numbers
- ["K994338"]
- PMA numbers
- not on file
- Product code
- DHR
- Firm FEI
- 1000125787
- Firm city
- Garden Grove
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28