Z-0937-2018 Class II Terminated
FDA device recall Z-0937-2018 was initiated by Randox Laboratories, Limited on August 8, 2017 and is designated Class II. 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 recall status is terminated (terminated September 5, 2018). Affected quantity: 450 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 8, 2017
- Termination Date
- September 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 kits
Product Description
Liquid Cardiac Control CQ5053
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 Pattern
Nationally
Code Information
Lot 4069CK