Recall Z-0903-2023— Randox Laboratories Ltd.

Name: FDA recall Z-0903-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-22

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2022-11-22. It names one FDA 510(k) clearance: K972608. Product: Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1. Reason: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range.

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-22
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K972608 — RANDOX ASSAYED SPECIFIC PROTEIN CONTROLRandox Laboratories, Ltd.·cleared 1997-08-04

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 Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

Reason for recall

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

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