Reported Jul 1, 2020 · Ongoing
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
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?
Atellica Solution IM1600 AnalyzerSiemens Material Number 11066000UDI # 00630414002026
- Lot codes and dates
Atellica Tube Top Sample Cups1 mLSMN 11069061Atellica Tube Top Sample Cups2 mLSMN 11069062Sarstedt 62.61215.3 x 92 False Bottom4 mL
- Amount recalled
- 1329
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
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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