Siemens Chek-Stix Control Strips Recalled for Potential Inaccurate Leukocyte Results
Siemens Healthcare Diagnostics Inc is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.
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 2/5 (Moderate).
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. The hazard involves potential inaccurate quality control results rather than direct patient harm, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 1,130 units of Chek-Stix Combo Pak (Catalog Number 1364N) positive and negative control strips for urine chemistry. The affected lots are C0099091A, P0099091A, C0100101 H, P0100101 H, C0103042C, and P0103042C. These products were distributed worldwide, including in the United States, Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore, Thailand, the Bahamas, South Wales, and Hong Kong.
The recall is due to a defect in the control material. When the specified lots are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25°C (77°F). This issue may affect the accuracy of urinalysis quality control procedures.
Users of these products should stop using the affected lots and contact Siemens Healthcare Diagnostics Inc for further instructions or a replacement.
The recalled product
- Product
- Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 1,130
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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 7 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 Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
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 results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateBeckman Coulter Recalls iChem 10 SG Urine Chemistry Strips
FDA (Devices) · 2016-01-20
- ModerateBeckman Coulter IRISpec glucose control false positive results with urine chemistry strips
FDA (Devices) · 2023-01-11
- ModerateBeckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives
FDA (Devices) · 2019-07-10
- ModerateBeckman Coulter Urine Chemistry Controls May Produce False Positive Results
FDA (Devices) · 2024-10-23
- ModerateBeckman Coulter Recalls iChem VELOCITY Urine Chemistry Strips Due to Defect
FDA (Devices) · 2018-05-23
- HighReagent Test Strips for Urinalysis Recalled Due to Missing Leukocytes Pad
FDA (Devices) · 2024-05-22