Reported Apr 29, 2015 · Terminated
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
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?
- ADVIA Chemistry Lipase Reagent
- Catalog Number B01-4840-01 REF01984894
- Lot codes and dates
- Catalog Number
B01-4840-01Material Number (SMN)10311896
- Lot Numbers
318706332463expiration dates 2015-06-302015-08-31
- Catalog Number
- Amount recalled
- 7814
Where it was sold
- Nationwide
Why it was recalled
Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents.
This product could cause temporary or reversible health problems — stop using it.
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