Recall – Automated immunodiagnostic system sensor error

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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.