Reported Aug 12, 2020 · Terminated
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for…
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
Is this the product you have?
- Randox Lipase AssayLipase Colorimetric
- R2 Substrate - Product UsageA Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma
- Lot codes and dates
- Catalogue Numbers
LI015/000/ULLI015/003/ULLI015/000/UL Lot #: 1049LI1051LI
- Catalogue Numbers
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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