Recall Z-1457-2015— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-03-23, terminated 2015-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-23
- Terminated
- 2015-12-18
- Firm location
- Tarrytown, NY, United States
Product description
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.