Siemens Total Iron Binding Capacity Reagent Cartridge Recall for Labeling Error
Siemens is recalling Total Iron Binding Capacity reagent cartridges because the stated analytical sensitivity in the instructions is no longer valid.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling error regarding the analytical sensitivity claim, with no reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is conducting a voluntary corrective action for the Dimension Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. This in vitro diagnostic test is intended to quantitatively measure Total Iron Binding Capacity in human serum.
The recall is being issued because the analytical sensitivity claim of 6 ug/dL (1.1 umol/L) listed in the Instructions for Use (IFU) is no longer valid. Siemens is modifying the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
The affected product is identified by Siemens Material Number (SMN) 10444944 and Catalog number DF84. Specific lot numbers and expiration dates are listed in the recall documentation. The product was distributed nationwide.
The recalled product
- Product
- Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Siemens Material Number (SMN) 10444944
- Catalog number DF84 -- lot numbers BA3016
- EXP 2013-01-16
- EC3045
- EXP 2013-02-14
- EA3073
- EXP 2013-03-14
- DC3102
- EXP 2013-04-12
- FC3122
- EXP 2013-05-02
- EA3157
- EXP 2013-06-06
- BB3184
- EXP 2013-07-03
- EC3219
- EXP 2013-08-07
- EC3220
- EXP 2013-08-08
- GA3248
Distribution
Distributed nationwide across the United States.
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