Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate diagnostic results, leading to potential medication dosing errors for transplant patients. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,423 units of Dimension Tacrolimus Flex reagent cartridges (DF107) and Dimension TACR CAL (DC107) calibrators. The affected units are specifically lot BB4087 (expiration 3/28/14) and lot 3BD029 (expiration 03/01/14). These products were distributed nationwide in the United States, including in Texas, North Carolina, Georgia, Tennessee, Utah, New Jersey, Michigan, Virginia, Arkansas, Louisiana, Missouri, Florida, Arizona, California, the District of Columbia, Pennsylvania, New Hampshire, Wisconsin, South Dakota, South Carolina, New Mexico, Maryland, and Indiana.
The recall was initiated due to confirmed complaints of low patient sample recovery. The TACR method is an in vitro diagnostic test used to quantitatively measure Tacrolimus in human whole blood. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing for kidney and liver transplant patients.
Healthcare facilities and laboratories should stop using the affected lots immediately. Siemens is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacr
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5,423
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 (5)
- TACR Flex Reagent cartridge
- material #10444938
- (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator
- material #10445012
- (DC 107) lot 3BD029 with expiration date 03/01/14.
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate diagnostic result
See all →- HighSiemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
FDA (Devices) · 2020-10-28
- ModerateBinding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
FDA (Devices) · 2020-03-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
- HighAbbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
FDA (Devices) · 2019-03-13