FDA recall Z-2490-2019

Product

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

Reason for recall

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

Distribution

Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

Key facts

Status

Terminated

Initiation date

2019-07-12

Report date

2019-09-18

Termination date

2020-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2490-2019