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.
FDA Recall Z-2134-2019 · Posted None
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Recalling FirmHycor Biomedical Inc
Recall StatusCompleted
Product CodeDHR
Date Initiated2018-02-21
Product Quantity207
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.
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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