Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection
Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). This medical device is intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 33,506 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because a rare variant of TSH, identified in a small cluster of patients, is not detected by the device. This limitation may result in inaccurate test results for patients with this specific variant.
Healthcare facilities and consumers should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The agency has classified this as a Class II recall.
The recalled product
- Product
- Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 33,506
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 (1)
- Per recall strategy.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →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 · inaccurate diagnostic
See all →- ModerateTosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- HighInstrumentation Laboratory Recalls 722 ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighLuminex Recalls ARIES C. difficile Assay Due to Seal Defects
FDA (Devices) · 2019-08-21
- HighLuminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects
FDA (Devices) · 2019-08-21
- ModerateHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
Similar recalls
- ModerateSiemens Recalls Dimension TSHL Reagent Cartridges Due to Biotin Labeling Error
FDA (Devices) · 2018-05-16
- ModerateSiemens Recalls Dimension Vista TSH Reagent Cartridges for Labeling Error
FDA (Devices) · 2018-05-16
- ModerateSiemens Dimension Vista TSH Reagent Cartridge Recall for Incorrect Biotin Units
FDA (Devices) · 2017-06-28
- ModerateSiemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results
FDA (Devices) · 2015-06-10
- ModerateSiemens Troponin I Reagent Cartridge Recalled for Positive Bias
FDA (Devices) · 2020-10-14
- HighSiemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy
FDA (Devices) · 2018-06-20