FDA (Devices) recall action 86114
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Randox Laboratories is recalling specific batches of Pancreatic Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.
Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.