FDA recall Z-0752-2024

Product

Calibration Serum Level 3 CAL2351

Reason for recall

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Distribution

US Nationwide and Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2023-11-20

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2024