Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.

FDA Recall Z-0703-05 · Posted 2005-04-13

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeJTC
Date Initiated2004-05-20
Date Terminated2006-07-22
Product Quantity9

Reason for Recall

When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.

Firm Action

Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program.

Root Cause

Other

Distribution Pattern

CA, FL, NH, PA, SD, TX, WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑