Class II — Randox Laboratories, Limited
| Recalling firm | RANDOX LABORATORIES, LTD. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Randox Liquid Cardiac Controls Catalogue Number CQ5051 |
| Quantity | 6,208 |
| 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, |
| Initiated | 2019-10-04 |
| Classified | 2019-11-15 |
| Terminated | 2020-07-06 |
| Recall number | Z-0412-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Randox Laboratories, Limited (Z-0412-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84044/
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