RANDOX LABORATORIES, LTD. recalls Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

Recall date

July 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2923-2020

FDA classification

Class II

Brand / firm

RANDOX LABORATORIES, LTD.

Sold / distributed

New Mexico, Massachusetts, WV. Foreign distribution to Bolivia BOSNIA AND HERZEGOVINA Brazil Colombia Costa Rica Cyprus Egypt France Greece Grenada India Iraq Italy Jordan Kazakhstan Kenya Lithuania Mauritius Nepal Nigeria Pakistan Peru Philippines Poland Portugal Qatar Romania Russia South Africa…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent