FDA recall Z-2923-2020

Product

Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent

Reason for recall

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.

Distribution

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 Thailand The Bahamas Turkey UAE UK Vietnam

Key facts

Status

Terminated

Initiation date

2020-07-10

Report date

2020-09-09

Termination date

2021-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin Colorado Antrim, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2923-2020