Recall Z-1619-2020 ยท DCN System, Test, C-Reactive Protein
The Binding Site Group, Ltd.
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
| Date | Mar 31, 2020 (initiated Apr 25, 2019) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | On 4/25/2019, a Customer Notice was issued by the firm's UK office to firm's US office. The US office was instructed to provide this information to the end customer within 24 hours of receiving the notification along with a form to fill out and return. The Customer Notice issued to the affected customer advises immediate quarantine and disposal of affected kits following local regulations. Customers were asked to pass on the customer notice and to all those who need to be aware within their organization or to any organization where potentially affected devices have been transferred. The cus |
| Quantity | 1 kit |
| Distribution | U.S.: FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161982 | C-Reactive Protein Kit for use on SPAPLUS The Binding Site Group, Apr 5, 2017 |