Reported Sep 9, 2020 · Terminated

Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent

Randox Laboratories, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: RANDOX LABORATORIES, LTD. · 34 Diamond Rd · Crumlin Colorado Antrim, N/A · N/A

Is this the product you have?

  • Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
Lot codes and dates
  • AY3855 GTIN 05055273200614
Amount recalled
105 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 17, 2021 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.