Siemens CLINITEK Atlas Control Strips Recalled for Potential Leukocyte Result Errors
Siemens is recalling CLINITEK Atlas Positive and Negative Control Strips because leukocyte results 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 indicates the product is not likely to cause adverse health consequences. The hazard is a potential inaccuracy in control results rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry (Catalog Number 5019). The recall involves 6,466 units 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 defect 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 issue affects the accuracy of the control strips when used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak.
Affected lot numbers include S9093061A, P9093061A, S9094081A, P9094081A, S0097091C, P0097091C, S0100101B, P0100101B, S0103042A, P0103042A, S0103042H, P0103042H, S0106062A, P0106062A, S9101022A, P9101022A, S9101022B, P9101022B, S9105052A, and P9105052A. Users should stop using these control strips and contact Siemens Healthcare Diagnostics Inc for instructions on return or replacement.
The recalled product
- Product
- Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 6,466
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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