FDAClass IINovember 27, 2019

Randox Liquid Cardiac Controls recall

Randox Liquid Cardiac Controls Catalogue Number CQ5052.

Why was Randox Liquid Cardiac Controls recalled?

Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

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?

Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Exp. 28Nov2019), 4312CK Exp. 28Jun2020) and 4315CK (Exp. 28Jun2020)

Product
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Recalling firm
Randox Laboratories, Limited
Quantity
7,505
Distribution
US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls