PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 26, 2019 Initiated: March 11, 2019 #Z-1785-2019

Product Description

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.

Details

Recalling Firm
Randox Laboratories Ltd.
Units Affected
11420 kits
Distribution
Product distributed to CA, DE, WV, and Puerto Rico.
Location
Crumlin (North), N/A

Frequently Asked Questions

What product was recalled?
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053. Recalled by Randox Laboratories Ltd.. Units affected: 11420 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 26, 2019. Severity: Moderate. Recall number: Z-1785-2019.