Recall Z-0752-2024— Randox Laboratories Ltd.

Name: FDA recall Z-0752-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-20

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-11-20. It names one FDA 510(k) clearance: K053153. Product: Calibration Serum Level 3 CAL2351. Reason: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-20
Firm location: Crumlin (North), N/A, 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 CAL2351

Reason for recall

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

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