Recall Z-2385-2010 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Sep 8, 2010 (initiated Dec 16, 2009) |
| Status | Terminated |
| Reason | Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples. |
| 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 con |
| Quantity | unknown - all lots involved |
| Distribution | Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE Dade Behring, Inc., Jan 28, 2000 |