Recall Z-2490-2019— Randox Laboratories Ltd.

Name: FDA recall Z-2490-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-12

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2019-07-12, terminated 2020-06-17. It names one FDA 510(k) clearance: K053153. 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: 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)..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Terminated
Initiated: 2019-07-12
Terminated: 2020-06-17
Firm location: Crumlin (North), Ireland

510(k) clearances named in this recall

1 on FDA's record

K053153 — RANDOX CALIBRATION SERUMRandox Laboratories, Ltd.·cleared 2006-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.