Liquid Cardiac Control CQ5053
This recall has been terminated (originally issued August 8, 2017).
- Recall Initiated
- August 8, 2017
- Terminated
- September 5, 2018
- Recall Number
- Z-0937-2018
- Quantity
- 450 kits
- Official Source
- View on FDA website ↗
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
Nationally
Lot / Code Info
Lot 4069CK
Root Cause
Unknown/Undetermined by firm
Action Taken
A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.
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