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