Recall Z-1363-2020 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jan 30, 2020 (initiated Dec 20, 2019) |
| Status | Terminated |
| Reason | Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. |
| 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 ha |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.