CLASS II Device recall · Reported 25 Mar 2020 · 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, for in-vitro diagnostic use, distributed in California. The recall was initiated on 6 Nov 2019 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-1500-2020
- FDA event ID
- 84909
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2019
- FDA classified
- 13 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2019 | Recall initiated by company | |
| 13 Mar 2020 | Classified by FDA | +128 days |
| 25 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Product as listed by the FDA
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Where it was distributed
Distributed in CA.
Questions about this recall
Why was it recalled?
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Which lots are affected?
Lot 428217 (Expiry date: 30-APR-2020
Where was it sold?
Distributed in CA.
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 |
|---|---|---|---|---|---|
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| Device | CLASS II | Freelite Human Lambda Free Kit (for use on the Spaplus) recalled | The Binding Site Group | Other | 13 states |
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| Device | CLASS II | Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | 10 states |
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