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 |
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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.
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510(K) Database | 510(K)s with Product Code = DHR
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