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U.S. Department of Health and Human Services

Class 2 Device Recall Autostat II Rheumatoid Factor IgM ELISA

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  Class 2 Device Recall Autostat II Rheumatoid Factor IgM ELISA see related information
Date Initiated by Firm February 21, 2018
Create Date July 30, 2019
Recall Status1 Completed
Recall Number Z-2134-2019
Recall Event ID 82952
510(K)Number K994338  
Product Classification System, test, rheumatoid factor - Product Code DHR
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.
Code Information Lot Number 154962
Recalling Firm/
Manufacturer		 Hycor Biomedical Inc
7272 Chapman Ave
Garden Grove CA 92841-2103
For Additional Information Contact
714-933-3000
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DHR and Original Applicant = COGENT DIAGNOTICS LTD.
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