Home / Recalls / Randox Laboratories Ltd. / Z-2425-2024

Z-2425-2024 Class II Ongoing

Recalled by Randox Laboratories Ltd. — Crumlin (North)

Recall Details

Product Type
Devices
Report Date
July 31, 2024
Initiation Date
June 7, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
115 kits

Product Description

RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

Reason for Recall

Cystatin C Reagent marketed without a 510 (k)

Distribution Pattern

US Nationwide distribution in the states of AL, CA, GA, NY.

Code Information

GTIN: 05055273208665 All lots

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  • Z-0753-2024 Class II — Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry as (November 20, 2023)
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