Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors due to contamination, which poses a risk of harm through inaccurate medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,559 units of Atellica CH Reaction Ring Segments (SMN 11099326, UDI 00630414596143). The recall covers specific lots distributed domestically nationwide and worldwide.
The recall is due to potential cuvette defects in some lots ending in "17", "18", "19", or higher. These defects may allow water from the water bath to contaminate the interior of the cuvette. This contamination may falsely elevate or depress sample results, potentially affecting the accuracy of diagnostic testing.
Healthcare facilities and distributors should identify and stop using the affected lots. Siemens Healthcare Diagnostics is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,559
Distribution
Distributed nationwide across the United States.
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