FDA recall Z-0381-2019

Product

Liquid Cardiac Control, CQ5052

Reason for recall

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

Distribution

Distributed to IN, NY, PR, and WV.

Key facts

Status

Terminated

Initiation date

2018-10-02

Report date

2018-11-14

Termination date

2019-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0381-2019