RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Brand
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
Lot Codes / Batch Numbers
AY3805 GTIN 05055273200607
Products Sold
AY3805 GTIN 05055273200607
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom is recalling Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent due to Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The consumers were sent a letter via email dated July 10, 2020. This notice instructs customers to The distributors and customers will be instructed to: -Discontinue use of batches listed above immediately -Review your reagent inventory of these products and assess your laboratories needs for replacements. Proof of remaining kits will be required. -Discuss the contents of this notice with your Medical Director. -Complete and return the response form
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA, NM, WV
Page updated: Jan 10, 2026