Z-0414-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 4, 2019
- Termination Date
- July 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,702
Product Description
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
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 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,
Code Information
Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)