FDA Recall
Terminated
Liquid Cardiac Control CQ5053
Recall: Z-0937-2018
·
Initiated August 8, 2017
Recall
- Recall Number
- Z-0937-2018
- Event Number
- 79035
- Firm
- Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 8, 2017
- Terminated
- September 5, 2018
Description
Liquid Cardiac Control CQ5053
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.
Action
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.
Distribution
Nationally
Quantity
450 kits