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Recall Observatory FDA recall evidence

Device product

Liquid Cardiac Control CQ5053

Z-0937-2018

August 08, 2017

Class II

Product summary

Firm
Randox Laboratories, Limited
Event
Event 79035
Status
Terminated
Classification
Class II
Quantity
450 kits
Official record key
device-enforcement:Z-0937-2018

Official wording

Reason: 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.

Code information: Lot 4069CK

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.