Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 9/21/2016
Class lI:

PRODUCT

RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Recall Number Z-2802-2016

REASON
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Norwood, MA on 9/14 2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
114 units

DISTRIBUTION
Nationwide and Internationally

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