FDA recall Z-0412-2020

Product

Randox Liquid Cardiac Controls Catalogue Number CQ5051

Reason for recall

Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

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,

Key facts

Status

Terminated

Initiation date

2019-10-04

Report date

2019-11-27

Termination date

2020-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2020