FDAFDA · Food and drugs·Recall number Z-2923-2020
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Published September 9, 2020 · Recall initiated: July 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RANDOX LABORATORIES, LTD.
- Distributor
- 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
- Lot
- AY3805 GTIN 05055273200607
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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