Siemens Acute Care CTNI TestPak Barcode Scanning Recall
Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (barcode scanning) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity issue.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Siemens Acute Care CTNI TestPak, an in vitro diagnostic test used to measure cardiac troponin I in heparinized plasma. The recall is due to a defect where the cartridge barcode labels may not scan on Stratus CS systems.
The affected products are identified by Catalog Number CCTNI and SMN 10445071. Specific lot numbers involved in this recall include 235151002, 235159002, 235166002, 235173002, 235208002, 235215002, 235222002, 235229002, 235236002, 235243002, 235250002, 235257002, 235278002, and 235285002.
These products were distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East. Healthcare facilities should check their inventory for these specific lot numbers and contact Siemens Healthcare Diagnostics Inc for further instructions on how to proceed.
The recalled product
- Product
- Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 5,558
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 (12)
- Lot Numbers: 235151002
- 235159002
- 235166002
- 235173002
- 235208002 235215002
- 235222002
- 235229002
- 235236002
- 235243002 235250002
- 235257002
- 235278002
- 235285002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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 11 products in this recall →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 · scanning defect
See all →- ModerateSiemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues
FDA (Devices) · 2016-01-13