FDA recall Z-1369-2024

Product

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Reason for recall

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

Distribution

US Nationwide distribution in the states of CA, IN.

Key facts

Status

Ongoing

Initiation date

2024-02-14

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2024