Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
- Recall Initiated
- March 11, 2019
- Terminated
- May 15, 2020
- Recall Number
- Z-1785-2019
- Quantity
- 11420 kits
Reason for Recall
Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
Distribution
Product distributed to CA, DE, WV, and Puerto Rico.
Lot / Code Info
lots 4243CK, 4244CK, 4245CK.
Root Cause
Under Investigation by firm
Action Taken
On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI). Customers were asked to do the following: * Inspect your stock and quarantine affected stock. " Replace the value sheet in the kit with the revised value sheet provided. " Randox is not recommending a review of previous results as changes in quality control recovery would be reviewed at the time of occurrence. " Discuss the contents of this notice with your Medical Director. " Complete the response form even if you no longer have the affected product. Return the response form to technical.services@randox.com within five working days.