FDAClass IINovember 14, 2018

Liquid Cardiac Control recall

Liquid Cardiac Control, CQ5053

Why was Liquid Cardiac Control recalled?

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

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?

All lots

Product
Liquid Cardiac Control, CQ5053
Recalling firm
Randox Laboratories Ltd.
Quantity
2108
Distribution
Distributed to IN, NY, PR, and WV.
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls