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.
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. 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 re
- 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.
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