—#179303

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.

FDA product code: CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: lot 485700

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

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.

Timeline

Recall initiated: 2019-12-20
Posted by FDA: 2020-01-30
Terminated: 2020-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.