Reported Mar 21, 2018 · Terminated

Liquid Cardiac Control CQ5053

Randox Laboratories, Limited

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, Limited · Ardmore 55 The Diamond Road · Crumlin · N/A

Is this the product you have?

  • Liquid Cardiac Control CQ5053
Lot codes and dates
  • Lot 4069CK
Amount recalled
450 kits

Why it was recalled

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

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

Notice updated Sep 5, 2018 · Data as of Sep 19, 6:17 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.