Device product
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Z-1619-2020
Product summary
- Event
- Event 84890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 kit
- Official record key
device-enforcement:Z-1619-2020
Official wording
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
Code information: Lot 455672
Distribution pattern: U.S.: FL
Derived failure modes
-
Unknown
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