Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors
Siemens Healthcare Diagnostics is recalling specific lots of 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a potential inaccuracy in control results rather than a direct patient safety hazard.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 325 units of the Siemens Chek-Stix Combo Pak (Catalog Number 1364M). These are positive and negative control strips used for urine chemistry testing. The affected lots are CP0099091B, P0099091B, C0100101G, P0100101G, C0103042E, and P0103042E.
The recall is due to a potential issue where 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.
The product was distributed worldwide, including the United States, Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore, Thailand, the Bahamas, South Wales, and Hong Kong. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M 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
- Affected units
- 325
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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