Recall Z-0339-2016— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0339-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-09-30, terminated 2016-09-01. It names one FDA 510(k) clearance: K061655. Product: Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.. Reason: Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-30
Terminated: 2016-09-01
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 System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.

Reason for recall

Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.

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