Home / Recalls / Randox Laboratories, Limited / Z-0937-2018

Z-0937-2018 Class II Terminated

Recalled by Randox Laboratories, Limited — Crumlin

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
August 8, 2017
Termination Date
September 5, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
450 kits

Product Description

Liquid Cardiac Control CQ5053

Reason for Recall

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

Distribution Pattern

Nationally

Code Information

Lot 4069CK

Other recalls by Randox Laboratories, Limited

  • Z-1018-2025 Class II — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) (December 20, 2024)
  • 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)