Recall Z-0402-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0402-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-08-25, terminated 2017-12-01. It names one FDA 510(k) clearance: K060264. Product: Dimension IRON Flex reagent cartridges. Reason: Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU)..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-08-25
Terminated: 2017-12-01
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.·cleared 2006-03-08

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 IRON Flex reagent cartridges

Reason for recall

Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

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