Recall Z-1563-2021— Randox Laboratories Ltd.

Name: FDA recall Z-1563-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-29

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2021-03-29, terminated 2021-11-22. It names one FDA 510(k) clearance: K053153. Product: Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351. Reason: Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Terminated: 2021-11-22
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

Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

Reason for recall

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

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