FDA recall Z-1619-2020

Product

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

U.S.: FL

Key facts

Status

Terminated

Initiation date

2019-04-25

Report date

2020-04-08

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2020