FDA recall Z-1759-2024

Randox Laboratories Ltd. · Class II · device

Product

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

Reason for recall

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Distribution

Domestic: Nationwide Distribution.

Key facts

Status
Ongoing
Initiation date
2024-03-05
Report date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2024