C-Reactive Protein Kit for use on the SPAplus — Class II medical device recall Z-1619-2020
Terminated recall by The Binding Site Group, Ltd., reported 2020-04-08, distributed in FL. A reagent in C reactive protein kits is not performing to specification and samples with known concentrations
| Recall number | Z-1619-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2019-04-25 |
| Classified | 2020-03-31 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-04-27 |
| Distributed | FL |
| Quantity | 1 kits |
| UPC / GTIN / UDI-DI | 05051700018456 |
| Lot numbers | 455672 |
| Model numbers | NK044.S.A |
Product
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1619-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.