Reported Aug 28, 2019 · Terminated
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma,…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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
- Lot codes and dates
- Lot # 5890128326 and Lot # 182670004
- UDI00842768012334
- Amount recalled
- 664 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Iincreased (falsely elevated) Albumin results compared to expected results
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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