CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
Rheumatoid Factor (RF) Kit for use on Spaplus recalled
The Binding Site Group is recalling Rheumatoid Factor (RF) Kit for use on Spaplus, Product #LK151.S.A Intended for the, distributed in California. The recall was initiated on 4 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0553-2018
- FDA event ID
- 78934
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2018
- FDA classified
- 8 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Jan 2018 | Recall initiated by company | |
| 8 Feb 2018 | Classified by FDA | +35 days |
| 14 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The low and high controls for the product are returning results above the assigned values.
Product as listed by the FDA
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
Where it was distributed
US Distribution was made to CA. There was no foreign/military/government distribution.
Questions about this recall
Why was it recalled?
The low and high controls for the product are returning results above the assigned values.
Which lots are affected?
Lot #416595, Exp. 31/03/2018; UDI #05051700018319
Where was it sold?
US Distribution was made to CA. There was no foreign/military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Binding Site Group
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Exent Analyser recalled by The Binding Site Group | The Binding Site Group | Potency & Assay | Nationwide |
| Device | CLASS II | Freelite Human Lambda Free Kit (for use on the Spaplus) recalled | The Binding Site Group | Other | 13 states |
| Device | CLASS II | Freelite Human Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | Nationwide |
| Device | CLASS II | Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | 10 states |
| Device | CLASS II | Optilite Rheumatoid Factor Kit recalled by The Binding Site Group | The Binding Site Group | Other | 20 states |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |