Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: Recalled by RANDOX LABORATORIES, LTD. Due to Randox have confirmed imprecision of quality control and...

Date: June 26, 2020
Company: RANDOX LABORATORIES, LTD.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RANDOX LABORATORIES, LTD. directly.

Affected Products

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

Why Was This Recalled?

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RANDOX LABORATORIES, LTD.

RANDOX LABORATORIES, LTD. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report