Z-2385-2010

Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro...

Name: Z-2385-2010 Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-12-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-12-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure... on 2009-12-16. The reason FDA records is "Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2385-2010
Status: Terminated
Initiated: 2009-12-16
Posted: 2010-09-08
Terminated: 2010-10-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
Reason for recall: Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an "Urgent Field Safety Notice" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.
Quantity in commerce: unknown - all lots involved
Distribution: Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.
Product codes and lots: Catalog number df84

Product code JMO

K994115Class ITotal Iron Binding Capacity (Ibct) Flex Reagent CartridgeDade Behring, Inc. / cleared 2000-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)