Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors
Siemens Healthcare Diagnostics is recalling Chek-Stix 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a potential error in a control strip result under specific storage conditions, not a direct patient safety hazard.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 700 units of Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Catalog Number 1360L). The recall affects specific lots identified by carton and bottle lot numbers C9094081C, P9094081C, C0100101A, P0100101A, C9101022C, and P9101022C. These products were distributed worldwide, including in the United States, Canada, and several other international locations.
The recall was initiated because the positive control solution may yield a negative leukocyte result if the reconstituted solution is held for more than two hours at temperatures above 25°C (77°F). This control material is used with Siemens reagent strips and tablets for urinalysis to provide defined results for various urine chemistry parameters.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled product. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 700
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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