Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status
Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.
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 the rubric defines as unlikely to cause adverse health consequences, and the issue is a regulatory marketing clearance error rather than a physical safety hazard.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling one unit of the CLINITEK Status+ Analyzer, a portable urine chemistry analyzer (Catalog number 10490946). The specific unit affected has Serial Number 212809 and was distributed in California. The recall was initiated because the device was configured with Sample Interference Notes (SIN) enabled, a configuration that was not cleared for US marketing.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the device is not likely to cause adverse health consequences. The issue is regulatory in nature, relating to the marketing clearance of the device's specific configuration rather than a reported safety defect or malfunction.
Consumers or healthcare facilities with this specific serial number should stop using the device and contact Siemens Healthcare Diagnostics Inc for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: 212809
Distribution
Distributed in 1 state:
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