Recall Z-0988-2013— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0988-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-10

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-10-10, terminated 2014-01-08. It names one FDA 510(k) clearance: K061818. Product: Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.. Reason: Correlation slope bias and accuracy shift.

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-10-10
Terminated: 2014-01-08
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K061818 — DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)Dade Behring, Inc.·cleared 2006-07-18

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 Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.

Reason for recall

Correlation slope bias and accuracy shift

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