FDA recall Z-2397-2019

Product

Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

Reason for recall

code 7-102 Liquid Sensor Error

Distribution

US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA

Key facts

Status

Terminated

Initiation date

2019-07-09

Report date

2019-09-04

Termination date

2022-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Uppsala, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2019