Company: Phadia Ab
Date of Enforcement Report: 9/4/2019
Class II

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.

• Recall Number: Z-2397-2019

REASON

Code 7-102 Liquid Sensor Error

RECALLING FIRM/MANUFACTURER

Phadia Ab on 7/9/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

387 Instruments

DISTRIBUTION

US Nationwide