CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report
C-Reactive Protein Kit for use on the SPAplus recalled
The Binding Site Group is recalling C-Reactive Protein Kit for use on the SPAplus, distributed in Florida. The recall was initiated on 25 Apr 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-1619-2020
- FDA event ID
- 84890
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2019
- FDA classified
- 31 Mar 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2019 | Recall initiated by company | |
| 31 Mar 2020 | Classified by FDA | +341 days |
| 8 Apr 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Product as listed by the FDA
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Where it was distributed
U.S.: FL
Questions about this recall
Why was it recalled?
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Which lots are affected?
Lot 455672
Where was it sold?
U.S.: FL
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.
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