Recall Z-0751-2024— Randox Laboratories Ltd.

Name: FDA recall Z-0751-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-13

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-11-13. It names one FDA 510(k) clearance: K053153. Product: Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532). Reason: There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-13
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. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

Reason for recall

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

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