Device product

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

Z-1785-2019

March 11, 2019

Class II

Product summary

Firm: Randox Laboratories Ltd.
Event: Event 82400
Status: Terminated
Classification: Class II
Quantity: 11420 kits
Official record key: device-enforcement:Z-1785-2019

Official wording

Reason: 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.

Code information: lots 4243CK, 4244CK, 4245CK.

Distribution pattern: Product distributed to CA, DE, WV, and Puerto Rico.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.