Device 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.
Z-1363-2020
Product summary
- Event
- Event 84768
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3224
- Official record key
device-enforcement:Z-1363-2020
Official wording
Reason: Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
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.
Derived failure modes
-
Unknown
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.