Recall Z-2134-2019 ยท DHR System, Test, Rheumatoid Factor
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
| Date | Feb 21, 2018 |
| Status | Completed |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA Cogent Diagnotics , Ltd., Feb 3, 2000 |