FDA recall Z-1435-2020

Product

Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.

Reason for recall

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status

Terminated

Initiation date

2020-01-06

Report date

2020-03-11

Termination date

2022-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1435-2020