Z-1363-2020Class II

ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 -

Name: Z-1363-2020 ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-12-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-12-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the... on 2019-12-20. FDA classified it as Class II and gives the reason as "Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1363-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-20
Posted: 2020-01-30
Terminated: 2020-12-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On December 20, 2019, the recalling firm distributed Urgent Medical Device Recall letters to affected customers. Customers were provided with instructions for determining whether the Lipase reagent cartons in their inventory were impacted. The next reagent lot is expected to be available by February 2020. Customers were asked to review the letter with their Medical Director, review their inventory for affected products, and assess their laboratory's replacement needs as applicable. A customer response form was included with the recall communication so that customers may confirm that they have received the notification as well as report the quantity of replacement product required.
Quantity in commerce: 3224
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
Product codes and lots: lot 485700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-26

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)