Home / Recalls / Randox Laboratories, Limited / Z-1018-2025

Z-1018-2025 Class II Ongoing

Recalled by Randox Laboratories, Limited — Crumlin

Recall Details

Product Type
Devices
Report Date
January 29, 2025
Initiation Date
December 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 kits

Product Description

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Reason for Recall

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Distribution Pattern

US Nationwide distribution Including PR.

Code Information

UDI-DI: 05055273209198 All lots within expiry

Other recalls by Randox Laboratories, Limited

  • Z-1017-2025 Class II — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a (December 20, 2024)
  • Z-1349-2020 Class II — RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (w (December 19, 2019)
  • Z-0414-2020 Class II — Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. (October 4, 2019)
  • Z-0413-2020 Class II — Randox Liquid Cardiac Controls Catalogue Number CQ5052. (October 4, 2019)
  • Z-0412-2020 Class II — Randox Liquid Cardiac Controls Catalogue Number CQ5051 (October 4, 2019)
  • Z-0367-2020 Class III — RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. (September 23, 2019)
  • Z-2083-2019 Class II — RX Daytona, Model Nos. RX4040 and RX4041 (June 24, 2019)
  • Z-2084-2019 Class II — RX Imola, Model Nos. RX4900 (June 24, 2019)
  • Z-2150-2019 Class II — Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This produ (June 11, 2019)
  • Z-2207-2019 Class III — Assayed Bovine Multi-Sera Level 1, Model No. AL1027 (June 10, 2019)