# FDA recall Z-1363-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-12-20.

## 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.

## 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

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.

## Key facts

- **Recall number:** Z-1363-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-20
- **Report date:** 2020-03-04
- **Termination date:** 2020-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2020

## Citation

> AI Analytics. FDA recall Z-1363-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1363-2020. Source: US FDA. Licensed CC0.

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