Recall Z-0553-2018 ยท DHR System, Test, Rheumatoid Factor
The Binding Site Group, Ltd.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
| Date | Jan 4, 2018 |
| Status | Terminated |
| Reason | The low and high controls for the product are returning results above the assigned values. |
| Root cause | Under Investigation by firm |
| Action | Binding Site sent an Urgent Field Safety Notice dated December 22, 2017. Advise on action to be taken by the User: " The new QC values detailed below should be used for the remainder of the shelf life of this Rheumatoid Factor Kit for use on SPAPLUS. "Input the revised QC values into your SPAPLUS instrument "Sign and return the TSWS18 E-Back Form accompanying this notification within 5 business days "Refer to Section 9 of the Product Insert SIN282(.A) if QCs are out of range following reassignment. For further questions, please call (858) 453-9177. |
| Quantity | 49 kits to the U.S. office (32 kits further distributed) |
| Distribution | US Distribution was made to CA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS The Binding Site Group , Ltd., Dec 7, 2016 |