Recall Z-2175-2012— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2175-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-07-17, terminated 2014-01-14. It names one FDA 510(k) clearance: K061655. Product: Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.. Reason: Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-07-17
Terminated: 2014-01-14
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.·cleared 2006-07-10

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

Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

Reason for recall

Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

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