FDA (Devices) recall action 86039
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
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 Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.
Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.
Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.