Device product
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Z-0412-2020
Product summary
- Event
- Event 84044
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,208
- Official record key
device-enforcement:Z-0412-2020
Official wording
Reason: 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.
Code information: 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)
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,
Derived failure modes
-
Unknown
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.