Recall Z-0541-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0541-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-18

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-09-18, terminated 2014-10-01. It names one FDA 510(k) clearance: K063206. Product: Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.. Reason: Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Terminated: 2014-10-01
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.·cleared 2006-12-28

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 Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Reason for recall

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

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