FDA recall Z-0157-2020

Product

Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Distribution

US Nationwide in the states of NY, and UT

Key facts

Status

Terminated

Initiation date

2012-01-10

Report date

2019-10-23

Termination date

2024-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dieren, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0157-2020