FDA recall Z-3305-2024

Product

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Reason for recall

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-08-21

Report date

2024-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3305-2024