Siemens Healthcare Diagnostics, Inc. recalls N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma,…
- Recall date
- June 27, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2341-2019
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Iincreased (falsely elevated) Albumin results compared to expected results
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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