Reported Apr 17, 2019 · Terminated
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro…
Randox Laboratories Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Liquid Immunoassay Premium Controls
- Model Number LIA3105 Product UsageThis product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
- Lot codes and dates
- Lot codes1723EC
- Amount recalled
- 4
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
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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