Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity
Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.
What this means for you
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 indicates the product is not likely to cause adverse health consequences. The issue is a functional defect in a control material that may lead to inaccurate test results, but no direct patient harm or injury is reported.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 7,865 units of Chek-Stix Positive and Negative Control Strips for Urine Chemistry, Catalog Number 1360. The recall covers specific lots 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 was initiated because the positive control solution's leukocyte result may become negative if the reconstituted solution is held for more than two hours at temperatures above 25°C (77°F). This temperature sensitivity can lead to inaccurate control results, potentially affecting the reliability of urinalysis testing.
Users of these control strips should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or a replacement. The affected lot numbers include C9093061B, P9093061B, C9094081B, P9094081B, C0097091B, P0097091B, C0100101C, P0100101C, C0103042F, P0103042F, C0106062B, P0106062B, C91 01022D, P91 01022D, CP9105052B, P9105052B, C9108092A, and P9108092A.
The recalled product
- Product
- Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 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 strip
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 7,865
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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