Z-1363-2020 Class II Terminated
FDA device recall Z-1363-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on December 20, 2019 and is designated Class II. Reason for recall: Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. The recall status is terminated (terminated December 21, 2020). Affected quantity: 3224.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- December 20, 2019
- Termination Date
- December 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3224
Product Description
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 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.
Code Information
lot 485700