FDAFDA · Food and drugs·Recall number Z-0414-2020
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Published November 27, 2019 · Recall initiated: October 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories, Limited
- Distributor
- 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,
- Lot
- Catalogue Number: CQ5053 GTIN: 05055273207460 Batch/lot: 4245CK (Exp. 28Nov2019), 4248CK (Exp. 28Nov2019), 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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