Recall Z-0937-2018
Randox Laboratories, Limited · initiated August 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Liquid Cardiac Control CQ5053
Codes / lots: Lot 4069CK
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.
FDA-determined 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.
Details
- Recall number
- Z-0937-2018
- Initiated
- August 8, 2017
- Terminated
- September 5, 2018
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 450 kits
- Distribution
- Nationally
- Recalling firm
- Randox Laboratories, Limited, Crumlin