27
Apr
2005

Inc. Class III Diasorin

0

Company: Diasorin, Inc
Date of Enforcement Report: 4/27/05
Class: III

PRODUCT
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. Recall # Z-0703-05.

REASON
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.

CODE
Version 7.

RECALLING FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by telephone on May 20, 2004 . Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 kits.

DISTRIBUTION
CA, FL, NH, PA, SD, TX, and WA.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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