Dec

2007

Inc., Cl IIl Ortho Clinical Diagnostics

Company: Medtronic Navigation, Inc
Date of Enforcement Report:12/26/2007
Class:lll

PRODUCT
Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 – April 4, 1999 to April 24, 2007 Product Code 936415F- Oct 26, 2005 to April 9, 2007 (F denotes refurbished), Recall # B-0156-08

REASON
The Sample Omission Monitoring (SOM) Calculations can be erroneous under very specific circumstances in which the Ortho Summit Sample Handling System (Summit) does not dispense Specimen Diluent into the A1 microwell of the assay plate.

RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, NJ, by letters on April 17, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
230 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

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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Inc., Cl IIl Ortho Clinical Diagnostics

Amy Sellers

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