Z-1619-2020 Class II Terminated

Recalled by The Binding Site Group, Ltd. — Birmingham, N/A

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