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Recall Observatory FDA recall evidence

Device product

Liquid Cardiac Control, CQ5051

Z-0380-2019

October 02, 2018

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 81159
Status
Terminated
Classification
Class II
Quantity
1763
Official record key
device-enforcement:Z-0380-2019

Official wording

Reason: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

Code information: All lots

Distribution pattern: Distributed to IN, NY, PR, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.