Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1363-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 20, 2019

Date Posted: March 4, 2020

Recall Number: Z-1363-2020

Event ID: 84768

Reason for Recall:

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

Status: Terminated

Product Quantity: 3224

Code Information:

lot 485700

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated