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
