Recall Z-1328-2024— Randox Laboratories Ltd.

Name: FDA recall Z-1328-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-01

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2024-03-01. It names one FDA 510(k) clearance: K061056. Product: Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.. Reason: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-01
Firm location: Crumlin (North), Ireland

510(k) clearances named in this recall

1 on FDA's record

K061056 — RANDOX LIQUID PROTEIN CALIBRATORRandox Laboratories, Ltd.·cleared 2006-07-20

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

Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

Reason for recall

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

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