Randox Laboratories, Limited: Medical Device Recall in 2019 - (Recall #: Z-0414-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

Product Classification:

Class II

Date Initiated: October 4, 2019

Date Posted: November 27, 2019

Recall Number: Z-0414-2020

Event ID: 84044

Reason for Recall:

Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

Status: Terminated

Product Quantity: 6,702

Code Information:

Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated