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Recall Observatory FDA recall evidence

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

December 20, 2019

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

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