FDA recall Z-1253-2023

Product

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Reason for recall

Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

Distribution

U.S. Nationwide distribution in the states of FL and GA.

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2023