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Total Iron Binding Capacity reagent cartridges because the stated analytical sensitivity in the instructions is no longer valid.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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issued because the analytical sensitivity claim of 6 ug/dL (1.1 umol/L) listed in the Instructions for Use (IFU) is no longer valid.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.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- HighSiemens magnesium reagent cartridges recalled for false measurement results
FDA (Devices) · 2025-01-01
- ModerateSiemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference
FDA (Devices) · 2020-04-01
- HighSiemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy
FDA (Devices) · 2018-06-20
- LowSiemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference
FDA (Devices) · 2016-11-23
- HighSiemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results
FDA (Devices) · 2012-12-12
- HighSiemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells
FDA (Devices) · 2024-09-18