Siemens ADVIA Chemistry Lipase Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase reagents due to customer complaints about failed calibrations and increased imprecision in quality control and patient samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths, only performance issues (failed calibrations and imprecision). This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where no direct harm is reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,224 units of ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446. The affected lot is 485700. This product is used for lipase measurements in the diagnosis and treatment of pancreatic diseases, such as acute pancreatitis and obstruction of the pancreatic duct.
The recall was initiated after the firm received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. The FDA has classified this as a Class II recall.
The product was distributed worldwide and nationwide in the United States, specifically in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, and WA. Healthcare facilities and laboratories should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,224
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot 485700
Distribution
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