Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product… recallZ-0553-2018 · The Binding Site Group, Ltd. · initiated Jan 4, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The low and high controls for the product are returning results above the assigned values.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0553-2018
- Status
- Terminated
- Initiated by the company
- Jan 4, 2018
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 49 kits to the U.S. office (32 kits further distributed)
- Product code
- DHR
- FDA submissions
- K160070
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
Product description
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
Code information (models, lots, serial numbers)
Lot #416595, Exp. 31/03/2018; UDI #05051700018319
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Rheumatoid Factor (RF) Kit for use on SPAPLUS LK151.S.AThe Binding Site Group Limited · System, Test, Rheumatoid Factor1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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