FDA recall Z-0387-2018

Product

Phadia 1000 Instrument, Article Number 12-3800-01.

Reason for recall

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-05

Report date

2018-01-24

Termination date

2018-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0387-2018