FDAClass IIMarch 21, 2018

Liquid Cardiac Control CQ5053 recall: Labeling Error

Liquid Cardiac Control CQ5053

Why was Liquid Cardiac Control CQ5053 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 4069CK

Product
Liquid Cardiac Control CQ5053
Recalling firm
Randox Laboratories, Limited
Quantity
450 kits
Distribution
Nationally
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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