FDA recall Z-1327-2020

Product

OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Reason for recall

There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

Distribution

CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,

Key facts

Status

Terminated

Initiation date

2019-07-29

Report date

2020-02-26

Termination date

2022-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2020