Reported Aug 12, 2020 · Terminated
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the…
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 Reagent - 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
LI3837LI7979LI8050
- LI8361 GTIN
05055273204230050552732042470505527320913605055273214284 Lot #: 507360497086497053497038502135
- Catalogue Numbers
- Amount recalled
- 2219 kits
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 reagent 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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