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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Ortho Assay Software (OAS) Version 2.0 (For Use with the Ortho Summit Sample Handling System)-Ortho Clinical Diagnostics, Inc

DATE NOTIFICATION INITIATED:

 

May 13, 2004


PRODUCT:

 

Ortho Assay Software; Version 2.0


MANUFACTURER:

 

Ortho Clinical Diagnostics, Inc.
Raritan, New Jersey


REASON:

 

Ortho Clinical Diagnostics (OCD) has received reports that sample or reagent could be dispensed twice if an 'Error 137' is generated during the pipetting of a plate. If the error is generated while fluid is being dispensed to a microplate, the instrument activity stops and the user is required to respond to the message. If the user chooses to "Continue" and the instrument is in the dispensing step, the dispense step may inadvertently be repeated. If an 'Error 137' occurs during pipetting, consignees are asked to follow the instructions described in OCD's "Important Information Notification" dated May 13, 2004.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448