Recall Z-1962-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1962-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-06

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2015-05-06, terminated 2017-08-02. It names one FDA 510(k) clearance: K073537. Product: The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.. Reason: D50 and D51 diagnostic error codes are not functional..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Terminated: 2017-08-02
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions Diagnostics·cleared 2008-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.

Reason for recall

D50 and D51 diagnostic error codes are not functional.

Data sourced from openFDA. This site is unofficial and independent of the FDA.