Optilite C-Reactive Protein Kit — Class II medical device recall Z-0671-2020
Terminated recall by The Binding Site Group, Ltd., reported 2019-12-18, distributed nationwide. Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
| Recall number | Z-0671-2020 |
|---|---|
| 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 | 2019-02-19 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 10 kits |
| UPC / GTIN / UDI-DI | 05051700018449 |
| Lot numbers | 437705 |
| Model numbers | NK044.OPT.A |
Product
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Reason for recall
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
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-0671-2020. 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.