Class II — Potential Health Hazard

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

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Recalled by RANDOX LABORATORIES, LTD. Due to Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855...

Date: July 10, 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

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

Quantity: 1497 units

Why Was This Recalled?

Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

Where Was This Sold?

This product was distributed to 1 state: WV

Affected (1 state)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