Reported May 7, 2014 · Terminated
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products…
Siemens Healthcare Diagnostics
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 · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
- Lot codes and dates
- Lots 326 through 333
- Amount recalled
- 5953 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
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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