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

FDA device recall Z-1363-2020 · posted 2020-01-30 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CHI

Quantity affected

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.

Date initiated

2019-12-20

Date posted

2020-01-30

Date terminated

2020-12-21

Location

Tarrytown, NY