Z-1457-2015Class II

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

Name: Z-1457-2015 ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-03-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-03-23 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894 on 2015-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1457-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2015-04-20
Terminated: 2015-12-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
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.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued an Urgent Medical Device Correction on March 23, 2015, notifying direct consignees about the product, problem, and action to be taken. Customers were instructed to follow the directions provided in the customer letter in the event that a Lipase outlier is observed. All customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions please call (312) 275-7795.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1457-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20

Product code CHI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)