FDA recall Z-1785-2019

Randox Laboratories Ltd. · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2019-03-11
Report date
2019-06-26
Termination date
2020-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2019