FDA recall Z-0943-2021

Product

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Reason for recall

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

Distribution

U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

Key facts

Status

Terminated

Initiation date

2020-11-18

Report date

2021-02-10

Termination date

2024-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2021