Company:Siemens Healthcare Diagnostics, Inc
Date of Enforcement Report: 7/8/2015
Class lI:
PRODUCT
The Rapidlab 1260 and Rapidlab 1265 systems are blood gas analyzers used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Recall Number Rapid Lab 1260: Z-1961-2015
Rapidlab 1265 Z-1962-2015
REASON
D50 and D51 Diagnostic error codes are not functional.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Walpole, MA on 5/6/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Rapidlab 1260: 122 devices
Rapidlab 1265: 2713 devices
DISTRIBUTION
Nationwide and Internationally
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