—#88527

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.

FDA product code: JMO — Ferrozine (Colorimetric) Iron Binding Capacity
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K994115
Affected lot / code info: Catalog number df84

Why it was recalled

Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.

Timeline

Recall initiated: 2009-12-16
Posted by FDA: 2010-09-08
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88527. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.