Recall Z-0800-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0800-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-17

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-12-17, terminated 2014-08-26. It names one FDA 510(k) clearance: K990346. Product: Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.. Reason: An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Terminated: 2014-08-26
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.·cleared 1999-05-21

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

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

Reason for recall

An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

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