FDA Device recall Z-0553-2018
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor i…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor i… by The Binding Site Group, citing the low and high controls for the product are returning results above the assigned values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0553-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-04 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA |
Product
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
Reason
The low and high controls for the product are returning results above the assigned values.
Identifiers
| code_info | Lot #416595, Exp. 31/03/2018; UDI #05051700018319 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2018%22
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