Device product
Liquid Cardiac Control CQ5053
Z-0937-2018
Product summary
- 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
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.