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.
FDA Recall Z-2385-2010 · Posted 2010-09-08
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJMO
Date Initiated2009-12-16
Date Terminated2010-10-25
Product Quantityunknown - all lots involved
Reason for Recall
Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.