ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Reported: April 29, 2015 Initiated: March 23, 2015 #Z-1457-2015
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 7814
- Distribution
- Worldwide Distribution - US (nationwide) Distribution and to the countries of : Thailand, Pakistan, Vatican, Guadeloupe, Reunion, French Polynesia , Serbia, Martinique, India, China, Singapore, Brazil, South Africa, Mexico, Canada, Israel, Australia, Egypt, Russian Federation, Indonesia, Rep. Korea (S) ,Unit.Arab Emir., Taiwan ,Argentina ,Chile, Malaysia ,Colombia, Peru, Kazakhstan, Paraguay, Vietnam, Algeria, Austria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Turkey.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 7814.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2015. Severity: Moderate. Recall number: Z-1457-2015.
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