Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results
Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.
What this means for you
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 and involves a risk of harm (falsely elevated test results) where specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 664 units of N Cuvette Segments for the BN ProSpec System. The product is used for the quantitative determination of proteins in serum, plasma, urine, and cerebrospinal fluid. The recall is due to the potential for increased, or falsely elevated, albumin results compared to expected values.
The affected units are identified by Lot # 5890128326 and Lot # 182670004, with UDI 00842768012334. The distribution pattern is listed as nationwide. The agency has classified this recall as Class II.
Healthcare facilities and consumers should stop using the affected N Cuvette Segments and contact Siemens Healthcare Diagnostics for further instructions or a replacement.
The recalled product
- Product
- N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 664
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)
- Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334
Distribution
Distributed nationwide across the United States.
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