Recall Z-0671-2020 ยท DCN System, Test, C-Reactive Protein
The Binding Site Group, Ltd.
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 diso
| Date | Dec 12, 2019 (initiated Feb 19, 2019) |
| Status | Terminated |
| Reason | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits |
| Root cause | Material/Component Contamination |
| Action | On 02/19/2019 an "URGENT FIELD SAFETY NOTICE" was communicated to the US customers informing them of an observed deterioration of the CRP NK044.OPT.A reagent material, lot number 437705 and that the Recalling firm has made the decision to remove the affected product lot from the market.. The Customers are instructed to: -Discontinue using the product immediately and to remove any remaining affected reagents from the Optilite instrument. -Dispose of any remaining product at the customer's facility following local regulations, -The Recalling Firm considers this issue is unlikely to impact on me |
| Quantity | 10 kits |
| Distribution | US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group , Ltd., Feb 28, 2018 |