Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Reported: November 27, 2019 Initiated: October 4, 2019 #Z-0414-2020
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.
Details
- Recalling Firm
- Randox Laboratories, Limited
- Units Affected
- 6,702
- 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,
- Location
- Crumlin, N/A
Frequently Asked Questions
What product was recalled? ▼
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.. Recalled by Randox Laboratories, Limited. Units affected: 6,702.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0414-2020.
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