Recall Z-1540-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1540-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-01-30, terminated 2019-05-16. It names one FDA 510(k) clearance: K061792. Product: Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.. Reason: May produce erroneously low results from specific well sets..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-30
Terminated: 2019-05-16
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K061792 — DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRIDade 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

Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.

Reason for recall

May produce erroneously low results from specific well sets.

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