Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1457-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

Product Classification:

Class II

Date Initiated: March 23, 2015

Date Posted: April 29, 2015

Recall Number: Z-1457-2015

Event ID: 70835

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.

Status: Terminated

Product Quantity: 7814

Code Information:

Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated