Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Check against the official notice below — it lists the full affected range.
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls catalogue number CQ5052 because recent lots showed a decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP), leading to the removal of claims for N-proBNP testing from the product. The affected lots are 4244CK, 4247CK, 4261CK, 4312CK, and 4315CK, with a total of 7,505 units distributed across the United States (including West Virginia, California, Delaware, New Jersey, New York, Georgia, Indiana, and Puerto Rico) and numerous countries worldwide.
The source document does not specify what action affected consumers or healthcare facilities should take regarding this recall.
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 CQ5052 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 CQ5052 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: 7,505 Lot/code info: Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Exp. 28Nov2019), 4312CK Exp. 28Jun2020) and 4315CK (Exp. 28Jun2020)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.