Z-1619-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- April 25, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit
Product Description
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
Distribution Pattern
U.S.: FL
Code Information
Lot 455672