FDA recall Z-0937-2018

Product

Liquid Cardiac Control CQ5053

Reason for recall

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-08-08

Report date

2018-03-21

Termination date

2018-09-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2018