FDA recall Z-0992-2024

Product

RX Series Copper (Cu) Assay Ref. Number CU2340

Reason for recall

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Distribution

US Nationwide distribution in the states of SC and OK.

Key facts

Status

Ongoing

Initiation date

2023-11-29

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2024