FDA recall Z-0903-2023

Product

Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

Reason for recall

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Distribution

US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.

Key facts

Status

Ongoing

Initiation date

2022-11-22

Report date

2023-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0903-2023