FDA recall Z-1367-2022

Product

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960

Reason for recall

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

Distribution

Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.

Key facts

Status

Ongoing

Initiation date

2022-05-26

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2022