Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 4,642 units of Chek-Stix Combo Pak (Catalog Number 1364E) positive and negative control strips for urine chemistry. 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).
The affected lots are C0099091C, P0099091C, C0100101F, P0100101F, C9101022I, P9101022I, C0103042D, P0103042D, C0106062E, and P0106062E. 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 FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E 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…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 4,642
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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