FDA recall Z-2753-2020

Product

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

Reason for recall

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.

Key facts

Status

Terminated

Initiation date

2020-06-26

Report date

2020-08-12

Termination date

2020-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin Colorado Antrim, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2020