Randox Liquid Cardiac Controls Catalogue Number CQ5051
Check against the official notice below — it lists the full affected range.
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls with catalogue number CQ5051 distributed in the United States and internationally. The recall affects six specific lot numbers (4243CK, 4246CK, 4249CK, 4260CK, 4311CK, and 4317CK) totaling 6,208 units. The company removed claims for N-proBNP (N-Terminal Pro-Brain Natriuretic Peptide) from this product because recent lots showed a decrease in recovery for this measurement.
In the United States, the product was distributed to West Virginia, California, Delaware, New Jersey, New York, Georgia, Indiana, and Puerto Rico. Outside the U.S., the product reached numerous countries including Canada, China, Japan, the Netherlands, Italy, the United Kingdom, and many others. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Quantity: 6,208 Lot/code info: Catalogue Number: CQ5051 GTIN: 05055273207446 Batch/lot: 4243CK (Exp. 28Nov2019), 4246CK (Exp. 28Nov2019), 4249CK (Exp. 28Nov2019), 4260CK (Exp. 28Nov2019), 4311CK (Exp. 28May2020), 4317CK (Exp. 28May2020)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.