FDA recall Z-0328-2022

Product

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Reason for recall

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

Distribution

US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.

Key facts

Status

Terminated

Initiation date

2021-11-01

Report date

2021-12-08

Termination date

2023-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2022