Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Check against the official notice below — it lists the full affected range.
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls with catalogue number CQ5053 due to a decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. The affected product was distributed across multiple U.S. states including West Virginia, California, Delaware, New Jersey, New York, Georgia, Indiana, and Puerto Rico, as well as internationally to numerous countries. The recall involves 6,702 units across four specific lots: batch 4245CK and 4248CK (both expiring November 28, 2019) and batch 4313CK and 4316CK (both expiring June 28, 2020).
The source document does not specify a remedy or recommended action for consumers who have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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: 6,702 Lot/code info: Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.