Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors
Siemens Healthcare Diagnostics 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 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 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 III, which is defined as unlikely to cause adverse health consequences. The issue is a potential inaccuracy in control results rather than a direct patient safety hazard like a device failure or contamination.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 16,711 units of Chek-Stix Combo Pak, Catalog Number 1364. These are positive and negative control strips used for urine chemistry testing. The product was distributed nationwide in the United States and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore, Thailand, the Bahamas, South Wales, and Hong Kong.
The recall is due to a potential issue with the leukocyte result. When the control material is 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 could lead to inaccurate quality control results for urinalysis testing.
Users of these control strips should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. The specific lot numbers affected are listed in the recall documentation.
The recalled product
- Product
- Siemens Chek-Stix Combo Pak Catalog Number: 1364 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 results for glucose…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 16,711
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.
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