Company: Data Innovations.
Date of Enforcement Report: 9/11/2013
Class ll:

PRODUCT

1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13
2. Data Innovations Instrument Manager software Model – Versions 8.12.01
Recall Number B-2299-13

REASON
Laboratory software, with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER
1. Data Innovations, South Burlington, VT on 1/2/2013. Voluntary: Firm Initiated recall is complete
2. Data Innovations, South Burlington, VT on 9/14/2012. Voluntary: Firm Initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide and Canada

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