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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.