Reported Apr 1, 2020 · Ongoing
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro…
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. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Chemistry QC Premium Plus, Cat. No. LAL4213
- GTIN 05055273209006 - Product UsageThis product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy
- Lot codes and dates
- Lot 306UL
- Amount recalled
- 186 total, 27 USA
Where it was sold
Why it was recalled
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
This product could cause temporary or reversible health problems — stop using it.
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