FDA recall Z-1363-2020

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.

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2019-12-20

Report date

2020-03-04

Termination date

2020-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2020